Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00555620
• Collaborator: (none)
• Enrollment: 76
• Locations: 3
• Arms: 2
• Duration (Months): 43
• Patients Per Site: 25.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Drug: capecitabine; Drug: oxaliplatin; Drug: sunitinib malate; Drug: capecitabine; Drug: cisplatin; Drug: sunitinib malate	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: capecitabine; Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.; Drug: oxaliplatin; Oxaliplatin is given 110mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.; Drug: sunitinib malate; sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.; Other Names: Sutent
Experimental: B	Drug: capecitabine; Capecitabine is given orally at 1000mg/m^2 twice a day for 14 days followed by 7 days of drug free period.; Drug: cisplatin; Cisplatin is given 80mg/m^2 through a vein on day 1 every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.; Drug: sunitinib malate; sunitinib is given orally 25mg/day for 14 days followed by 7 days of drug free period.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With First-cycle Dose Limiting Toxicities (DLTs) [Baseline up to Day 21]

   Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.

Secondary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662) [Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]

2. Cmax of CAP [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

3. Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR) [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

4. Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR) [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

5. Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU) [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

6. Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662) [Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]

7. Cmin of CAP [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

8. Cmin of 5'DFCR [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

9. Cmin of 5'DFUR [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

10. Cmin of 5-FU [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

11. Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662) [Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]

12. Tmax for CAP [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

13. Tmax for 5'DFCR [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

14. Tmax for 5'DFUR [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

15. Tmax for 5-FU [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

16. Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662) [Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

17. t1/2 for CAP [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

18. t1/2 for 5'DFCR [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

19. t1/2 for 5'DFUR [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

20. t1/2 for 5-FU [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

21. Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662) [Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)]

    Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.

22. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

    AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

23. Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU [Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)]

    AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)

24. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)]

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

25. AUClast for 5'DFCR [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)]

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

26. AUClast for 5'DFUR [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)]

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

27. AUClast for 5-FU [Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)]

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

28. Percentage of Participants With Objective Response [Baseline, Day 21 of every even-numbered cycle up to 15 months]

    Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

29. Duration of Response (DR) [Baseline up to Month 15]

    DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.

30. Progression-Free Survival (PFS) [Baseline up to Month 15]

    PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• confirmed diagnosis of stomach cancer

• advanced stomach cancer of stage IV

• adequate blood chemistry, blood counts and kidney function

• willing to participate to study requirements and sign an informed consent document

Exclusion Criteria:

• prior chemotherapy for the stomach cancer in its advanced stage

• excessive toxicities related to prior therapies

• pregnant or breastfeeding patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707
2	Pfizer Investigational Site	Goyang	Gyeonggi	Korea, Republic of	410-769
3	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00555620
• Other Study ID Numbers: A6181126
• First Posted: Nov 8, 2007
• Last Update Posted: Jan 14, 2013
• Last Verified: Jan 1, 2013

• Additional relevant MeSH terms: Stomach Neoplasms; Capecitabine; Oxaliplatin; Sunitinib

Study Results

Participant Flow

Arm/Group Title	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Period Title: Overall Study
STARTED	6	7	15	23	3	22
COMPLETED	0	0	0	0	0	0
NOT COMPLETED	6	7	15	23	3	22

Baseline Characteristics

Arm/Group Title	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	Total
Arm/Group Description	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	Total of all reporting groups
Overall Participants	6	7	15	23	3	22	76
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.2 (5.8)	50.0 (12.4)	50.9 (11.3)	54.3 (10.1)	63.3 (11.6)	50.1 (11.5)	52.4 (10.9)
Sex: Female, Male (Count of Participants)
Female	0 0%	2 28.6%	6 40%	6 26.1%	1 33.3%	8 36.4%	23 30.3%
Male	6 100%	5 71.4%	9 60%	17 73.9%	2 66.7%	14 63.6%	53 69.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With First-cycle Dose Limiting Toxicities (DLTs)
Description	Any DLT event in Cycle 1: Grade (GR) 3/4 nausea, vomiting, or diarrhea despite anti-emetics, anti-diarrheals; GR 3 nonhematological toxicity for greater than or equal to (≥)7 days (except alopecia, skin or hair discoloration, hyperamylasemia, or hyperlipasemia without other clinical evidence of pancreatitis and asymptomatic hyperuricemia); GR 4 nonhematological toxicity; GR 4 neutropenia ≥7 days or thrombocytopenia; GR ≥3 febrile neutropenia or neutropenic infection; GR 3 thrombocytopenia ≥7 days; any treatment-related toxicity having >3 consecutive CAP or SU missed doses per cycle; delayed toxicity recovery >14 days.
Time Frame	Baseline up to Day 21

Outcome Measure Data

Analysis Population Description

DLT subpopulation analysis set population: all participants who received at least 1 dose of study drug and did not permanently discontinue during the first cycle of treatment for reasons other than a DLT or miss more than 3 consecutive doses of sunitinib or capecitabine for reasons other than for drug related toxicities within the first cycle.

Arm/Group Title	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	6	6	14	21	3	22
Number [participants]	1 16.7%	0 0%	3 20%	2 8.7%	2 66.7%	0 0%

2. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of SU, SU012662 (Metabolite of SU), and Total Drug (SU + SU012662)
Time Frame	Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cmax SU011248	40.1 (10.8)	69.7 (17.6)	46.5 (10.8)
Cmax SU012662	14.0 (11.3)	23.7 (9.9)	16.6 (3.3)
Cmax total drug (SU011248+SU012662)	53.9 (22.1)	93.0 (24.9)	62.4 (13.4)

3. Secondary Outcome

Title	Cmax of CAP
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	7000 (7354)	2051 (1109)	11681 (8034)
Cycle 1, Day 14	20491 (27098)	1989 (1686)	16276 (15832)

4. Secondary Outcome

Title	Cmax of 5'-Deoxy-5-fluorocytidine (Metabolite of CAP, 5'DFCR)
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	4800 (863)	3352 (1255)	8017 (3692)
Cycle 1, Day 14	5500 (5982)	2267 (933)	8036 (3540)

5. Secondary Outcome

Title	Cmax of 5'-Deoxy-5-fluorouridine (Metabolite of CAP, 5'DFUR)
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	4010 (1909)	2891 (1099)	7166 (4073)
Cycle 1, Day 14	6259 (7381)	2074 (765)	10082 (5421)

6. Secondary Outcome

Title	Cmax of 5-fluorouracil (Metabolite of CAP, 5-FU)
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	176 (127)	165 (63)	495 (326)
Cycle 1, Day 14	552 (641)	153 (78)	866 (473)

7. Secondary Outcome

Title	Minimum Observed Plasma Trough Concentration (Cmin) of SU, SU012662, and Total Drug (SU + SU012662)
Time Frame	Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) analysis set population: all participants who received sunitinib and had sufficient plasma concentration data to facilitate calculation of the PK parameters; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cmin SU011248	29.0 (5.2)	49.2 (13.0)	30.2 (9.2)
Cmin SU012662	11.9 (9.3)	18.7 (7.9)	11.1 (2.6)
Cmin total drug (SU011248+SU012662)	41.6 (15.6)	68.5 (16.4)	41.8 (11.3)

8. Secondary Outcome

Title	Cmin of CAP
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	24.8 (35.1)	0.0 (0.0)	0.0 (0.0)
Cycle 1, Day 14	32.0 (45.2)	0.0 (0.0)	0.0 (0.0)

9. Secondary Outcome

Title	Cmin of 5'DFCR
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	11.1 (15.7)	13.0 (20.7)	55.60 (100.9)
Cycle 1, Day 14	50.5 (71.4)	0.00 (0.00)	0.00 (0.00)

10. Secondary Outcome

Title	Cmin of 5'DFUR
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	0.0 (0.0)	2.4 (7.1)	34.4 (69.0)
Cycle 1, Day 14	33.5 (47.4)	0.0 (0.0)	0.0 (0.0)

11. Secondary Outcome

Title	Cmin of 5-FU
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	0.0 (0.0)	0.0 (0.0)	0.8 (2.5)
Cycle 1, Day 14	0.0 (0.0)	0.0 (0.0)	0.0 (0.0)

12. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) for SU, SU012662, and Total Drug (SU + SU012662)
Time Frame	Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Tmax SU011248	4.0	8.0	8.0
Tmax SU012662	9.0	8.0	6.0
Tmax total drug (SU011248+SU012662)	4.0	8.0	6.0

13. Secondary Outcome

Title	Tmax for CAP
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	4.3	2.0	0.5
Cycle 1, Day 14	0.3	2.0	0.4

14. Secondary Outcome

Title	Tmax for 5'DFCR
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	4.3	2.0	0.6
Cycle 1, Day 14	0.4	3.0	0.5

15. Secondary Outcome

Title	Tmax for 5'DFUR
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	4.5	2.0	0.8
Cycle 1, Day 14	0.4	3.0	0.5

16. Secondary Outcome

Title	Tmax for 5-FU
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	4.5	2.0	0.6
Cycle 1, Day 14	0.4	3.0	0.5

17. Secondary Outcome

Title	Terminal Elimination Half-Life (t1/2) for SU, SU012662, and Total Drug (SU + SU012662)
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Outcome Measure Data

Analysis Population Description

Not analyzed; t1/2 could not be accurately estimated due to the long t1/2 of SU and its active metabolite and due to short PK collection period of only 24 hrs.

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	0	0	0

18. Secondary Outcome

Title	t1/2 for CAP
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	1	1	9
Cycle 1, Day 1	0.3 (NA)	0.3 (NA)	0.4 (0.11)
Cycle 1, Day 14	0.4 (NA)	0.5 (NA)	0.4 (0.12)

19. Secondary Outcome

Title	t1/2 for 5'DFCR
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	1	6	10
Cycle 1, Day 1	0.7 (NA)	1.0 (0.4)	0.8 (0.2)
Cycle 1, Day 14	0.7 (NA)	1.1 (0.7)	0.8 (0.1)

20. Secondary Outcome

Title	t1/2 for 5'DFUR
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	1	5	10
Cycle 1, Day 1	0.7 (NA)	1.0 (0.4)	0.7 (0.1)
Cycle 1, Day 14	0.6 (NA)	1.0 (0.5)	0.7 (0.1)

21. Secondary Outcome

Title	t1/2 for 5-FU
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose); Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	1	2	9
Cycle 1, Day 1	0.8 (NA)	1.2 (0.8)	0.6 (0.1)
Cycle 1, Day 14	0.6 (NA)	1.1 (0.4)	0.6 (0.1)

22. Secondary Outcome

Title	Area Under the Curve From Time 0 to 24 Hours Postdose (AUC [0-24]) for SU, SU012662, and Total Drug (SU + SU012662)
Description	Area under the plasma concentration-time curve from time 0 to 24 hours postdose (0-24), also considered the AUC between doses at steady state.
Time Frame	Day 14 of Cycle 1 (predose and 2, 4, 6, 8, 10, and 24 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
AUC (0-24) SU011248	844 (155)	1420 (379)	902 (230)
AUC (0-24) SU012662	321 (254)	524 (219)	327 (64)
AUC (0-24) total drug (SU011248+SU012662)	1163 (407)	1944 (533)	1230 (273)

23. Secondary Outcome

Title	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]: CAP, 5'DFCR, 5'DFUR, and 5-FU
Description	AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	1	7	10
CAP (n = 1, 4, 10)	7480 (NA)	2828 (215)	8069 (3877)
5'DFCR (n = 1, 7, 10)	9200 (NA)	8853 (1648)	11467 (2476)
5'DFUR (n = 1, 6, 10)	7770 (NA)	5703 (1295)	9099 (2288)
5-FU (n = 1, 5, 9)	386 (NA)	285 (119)	489 (190)

24. Secondary Outcome

Title	Area Under the Curve From Time Zero to 12 Hours [AUC (12)] for CAP, 5'DFCR, 5'DFUR, and 5-FU
Description	AUC (12) = Area under the plasma concentration versus time curve from time zero (predose) to the extrapolated time 12 hours postdose. It is obtained from AUC (0 - last) plus AUC (last - 12)
Time Frame	Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	1	7	10
CAP (n = 1, 4, 9)	25435 (NA)	2663 (452)	8865 (6533)
5'DFCR (n = 1, 7, 10)	15522 (NA)	7087 (1222)	10091 (2847)
5'DFUR (n = 1, 6, 10)	15522 (NA)	4822 (1222)	10291 (3675)
5-FU (n = 1, 5, 10)	1299 (NA)	353 (141)	842 (403)

25. Secondary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CAP
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	7555 (135)	2899 (1580)	7373 (4199)
Cycle 1, Day 14	13532 (16648)	3157 (1171)	8213 (6432)

26. Secondary Outcome

Title	AUClast for 5'DFCR
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	12815 (5494)	8028 (1963)	11229 (2516)
Cycle 1, Day 14	8614 (8477)	6464 (1377)	9776 (2868)

27. Secondary Outcome

Title	AUClast for 5'DFUR
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	8855 (1761)	5658 (1237)	8951 (2248)
Cycle 1, Day 14	8500 (9192)	4829 (1015)	10017 (3637)

28. Secondary Outcome

Title	AUClast for 5-FU
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time Frame	Day 1 of Cycle 1 (0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours postdose) and Day 14 of Cycle 1 (predose and 0.25, 0.5, 1, 2, 3, 4, 8, and 10 hours)

Outcome Measure Data

Analysis Population Description

PK analysis set population; Number of participants analyzed (N): participants with evaluable data; n: participants with evaluable data for specified category

Arm/Group Title	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	2	9	10
Cycle 1, Day 1	355 (27)	291 (95)	506 (200)
Cycle 1, Day 14	688 (802)	350 (129)	854 (390)

29. Secondary Outcome

Title	Percentage of Participants With Objective Response
Description	Percentage of participants with an objective response-based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as the disappearance of all target lesions. PR defined as ≥30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame	Baseline, Day 21 of every even-numbered cycle up to 15 months

Outcome Measure Data

Analysis Population Description

Efficacy analysis set population: all participants enrolled in the study who received at least 1 dose of study medication (SU011248).

Arm/Group Title	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	6	7	15	23	3	22
Number (95% Confidence Interval) [percentage of participants]	16.7 278.3%	42.9 612.9%	46.7 311.3%	43.5 189.1%	0 0%	45.5 206.8%

30. Secondary Outcome

Title	Duration of Response (DR)
Description	DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first.
Time Frame	Baseline up to Month 15

Outcome Measure Data

Analysis Population Description

Efficacy analysis set population; No participants in the SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2 reporting group analyzed; all had stable disease during specified time frame

Arm/Group Title	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	1	3	7	10	10
Median (Full Range) [months]	14.1	6.3	10.5	5.9	6.3

31. Secondary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS defined as time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Time Frame	Baseline up to Month 15

Outcome Measure Data

Analysis Population Description

Efficacy analysis subset of population of participants who had an event

Arm/Group Title	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2	SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2	SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.	SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
Measure Participants	6	6	11	16	3	17
Median (95% Confidence Interval) [months]	3.2	6.6	6.4	8.0	2.8	5.5

Adverse Events

Adverse Event Reporting Description	The same event may appear as an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be serious in 1 participant and nonserious in another, or 1 participant may have experienced both a serious and nonserious event during the study. Event assessments were made on a regular schedule as per protocol.
Arm/Group Title	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2		SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2		SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2		SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2		SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2		SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
Arm/Group Description	Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.		SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.		SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.		SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.		SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.		SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
All Cause Mortality
	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2		SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2		SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2		SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2		SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2		SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2		SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2		SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2		SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2		SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2		SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)		2/7 (28.6%)		8/15 (53.3%)		8/23 (34.8%)		0/3 (0%)		5/22 (22.7%)
Blood and lymphatic system disorders
Anaemia	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Febrile neutropenia	0/6 (0%)		0/7 (0%)		2/15 (13.3%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Neutropenia	0/6 (0%)		1/7 (14.3%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Thrombocytopenia	0/6 (0%)		1/7 (14.3%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Gastrointestinal disorders
Abdominal pain	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Diarrhoea	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Duodenal perforation	0/6 (0%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Gastric perforation	0/6 (0%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Gastrointestinal haemorrhage	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Nausea	1/6 (16.7%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Vomiting	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
General disorders
Fatigue	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Pyrexia	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		1/22 (4.5%)
Sudden death	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Hepatobiliary disorders
Cholecystitis	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Infections and infestations
Infection	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Pneumonia	0/6 (0%)		1/7 (14.3%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		1/22 (4.5%)
Pyelonephritis	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Pyelonephritis acute	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Urinary tract infection	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Infectious peritonitis	0/6 (0%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Hyperglycaemia	0/6 (0%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Nervous system disorders
Cerebral haemorrhage	0/6 (0%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		1/22 (4.5%)
Psychiatric disorders
Suicide attempt	0/6 (0%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Reproductive system and breast disorders
Menorrhagia	0/6 (0%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/6 (16.7%)		1/7 (14.3%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		2/22 (9.1%)
Vascular disorders
Deep vein thrombosis	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Haemorrhage	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2		SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2		SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2		SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2		SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2		SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/6 (100%)		7/7 (100%)		15/15 (100%)		23/23 (100%)		3/3 (100%)		22/22 (100%)
Blood and lymphatic system disorders
Anaemia	4/6 (66.7%)		4/7 (57.1%)		9/15 (60%)		8/23 (34.8%)		1/3 (33.3%)		2/22 (9.1%)
Leukopenia	3/6 (50%)		3/7 (42.9%)		0/15 (0%)		1/23 (4.3%)		1/3 (33.3%)		1/22 (4.5%)
Neutropenia	5/6 (83.3%)		6/7 (85.7%)		15/15 (100%)		18/23 (78.3%)		2/3 (66.7%)		18/22 (81.8%)
Thrombocytopenia	4/6 (66.7%)		6/7 (85.7%)		10/15 (66.7%)		16/23 (69.6%)		2/3 (66.7%)		8/22 (36.4%)
Ear and labyrinth disorders
Hearing impaired	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Tinnitus	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Eye disorders
Eyelid oedema	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		4/23 (17.4%)		1/3 (33.3%)		0/22 (0%)
Vision blurred	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Gastrointestinal disorders
Abdominal discomfort	0/6 (0%)		1/7 (14.3%)		1/15 (6.7%)		5/23 (21.7%)		1/3 (33.3%)		4/22 (18.2%)
Abdominal distension	1/6 (16.7%)		1/7 (14.3%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Abdominal pain	4/6 (66.7%)		4/7 (57.1%)		7/15 (46.7%)		6/23 (26.1%)		1/3 (33.3%)		10/22 (45.5%)
Abdominal pain upper	3/6 (50%)		2/7 (28.6%)		3/15 (20%)		9/23 (39.1%)		0/3 (0%)		6/22 (27.3%)
Anal haemorrhage	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Cheilitis	0/6 (0%)		1/7 (14.3%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Constipation	4/6 (66.7%)		3/7 (42.9%)		7/15 (46.7%)		8/23 (34.8%)		0/3 (0%)		5/22 (22.7%)
Diarrhoea	2/6 (33.3%)		3/7 (42.9%)		6/15 (40%)		12/23 (52.2%)		0/3 (0%)		11/22 (50%)
Dry mouth	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Dyspepsia	1/6 (16.7%)		1/7 (14.3%)		6/15 (40%)		5/23 (21.7%)		1/3 (33.3%)		3/22 (13.6%)
Epigastric discomfort	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Gastrooesophageal reflux disease	0/6 (0%)		0/7 (0%)		0/15 (0%)		3/23 (13%)		0/3 (0%)		0/22 (0%)
Gingival pain	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Haematochezia	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Ileus	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Melaena	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Nausea	3/6 (50%)		6/7 (85.7%)		12/15 (80%)		17/23 (73.9%)		2/3 (66.7%)		17/22 (77.3%)
Rectal tenesmus	0/6 (0%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		1/3 (33.3%)		0/22 (0%)
Stomatitis	5/6 (83.3%)		3/7 (42.9%)		8/15 (53.3%)		10/23 (43.5%)		1/3 (33.3%)		7/22 (31.8%)
Toothache	1/6 (16.7%)		0/7 (0%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Vomiting	0/6 (0%)		4/7 (57.1%)		5/15 (33.3%)		8/23 (34.8%)		0/3 (0%)		7/22 (31.8%)
General disorders
Asthenia	0/6 (0%)		1/7 (14.3%)		1/15 (6.7%)		3/23 (13%)		0/3 (0%)		1/22 (4.5%)
Chest discomfort	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		1/3 (33.3%)		2/22 (9.1%)
Chest pain	1/6 (16.7%)		0/7 (0%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		1/22 (4.5%)
Chills	0/6 (0%)		0/7 (0%)		2/15 (13.3%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Face oedema	1/6 (16.7%)		2/7 (28.6%)		0/15 (0%)		7/23 (30.4%)		1/3 (33.3%)		2/22 (9.1%)
Fatigue	6/6 (100%)		6/7 (85.7%)		5/15 (33.3%)		9/23 (39.1%)		1/3 (33.3%)		8/22 (36.4%)
Mucosal inflammation	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Oedema	1/6 (16.7%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		2/22 (9.1%)
Oedema peripheral	1/6 (16.7%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		2/22 (9.1%)
Pain	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Pyrexia	0/6 (0%)		1/7 (14.3%)		1/15 (6.7%)		4/23 (17.4%)		0/3 (0%)		2/22 (9.1%)
Hepatobiliary disorders
Cholangitis	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Hepatotoxicity	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Hyperbilirubinaemia	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		5/23 (21.7%)		2/3 (66.7%)		2/22 (9.1%)
Jaundice	0/6 (0%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		1/3 (33.3%)		0/22 (0%)
Immune system disorders
Hypersensitivity	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Infections and infestations
Herpes zoster	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		1/3 (33.3%)		0/22 (0%)
Infection	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Nasopharyngitis	0/6 (0%)		0/7 (0%)		3/15 (20%)		1/23 (4.3%)		0/3 (0%)		2/22 (9.1%)
Staphylococcal bacteraemia	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Upper respiratory tract infection	1/6 (16.7%)		1/7 (14.3%)		2/15 (13.3%)		2/23 (8.7%)		0/3 (0%)		1/22 (4.5%)
Urinary tract infection	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Pericoronitis	0/6 (0%)		2/7 (28.6%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Investigations
Alanine aminotransferase increased	0/6 (0%)		1/7 (14.3%)		1/15 (6.7%)		4/23 (17.4%)		1/3 (33.3%)		3/22 (13.6%)
Aspartate aminotransferase increased	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		5/23 (21.7%)		1/3 (33.3%)		1/22 (4.5%)
Blood bilirubin increased	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		1/3 (33.3%)		0/22 (0%)
Blood creatinine increased	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Haemoglobin decreased	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		1/22 (4.5%)
International normalised ratio increased	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Liver function test abnormal	0/6 (0%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		1/3 (33.3%)		0/22 (0%)
Platelet count	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		1/22 (4.5%)
Weight decreased	0/6 (0%)		0/7 (0%)		3/15 (20%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Metabolism and nutrition disorders
Decreased appetite	5/6 (83.3%)		6/7 (85.7%)		11/15 (73.3%)		15/23 (65.2%)		3/3 (100%)		13/22 (59.1%)
Hyperglycaemia	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		1/22 (4.5%)
Hyperkalaemia	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Hypocalcaemia	0/6 (0%)		1/7 (14.3%)		2/15 (13.3%)		1/23 (4.3%)		0/3 (0%)		1/22 (4.5%)
Hypokalaemia	0/6 (0%)		1/7 (14.3%)		2/15 (13.3%)		2/23 (8.7%)		0/3 (0%)		1/22 (4.5%)
Hypomagnesaemia	0/6 (0%)		1/7 (14.3%)		2/15 (13.3%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Hyponatraemia	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Hypophosphataemia	0/6 (0%)		0/7 (0%)		2/15 (13.3%)		3/23 (13%)		0/3 (0%)		2/22 (9.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Back pain	2/6 (33.3%)		0/7 (0%)		1/15 (6.7%)		3/23 (13%)		0/3 (0%)		3/22 (13.6%)
Flank pain	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		1/3 (33.3%)		1/22 (4.5%)
Myalgia	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Pain in extremity	1/6 (16.7%)		0/7 (0%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Nervous system disorders
Dizziness	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		2/23 (8.7%)		0/3 (0%)		6/22 (27.3%)
Dysgeusia	1/6 (16.7%)		1/7 (14.3%)		1/15 (6.7%)		7/23 (30.4%)		0/3 (0%)		1/22 (4.5%)
Headache	0/6 (0%)		1/7 (14.3%)		3/15 (20%)		4/23 (17.4%)		0/3 (0%)		5/22 (22.7%)
Hyperaesthesia	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Neuropathy peripheral	0/6 (0%)		1/7 (14.3%)		2/15 (13.3%)		6/23 (26.1%)		1/3 (33.3%)		8/22 (36.4%)
Paraesthesia	0/6 (0%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		1/3 (33.3%)		0/22 (0%)
Peripheral sensory neuropathy	1/6 (16.7%)		1/7 (14.3%)		3/15 (20%)		6/23 (26.1%)		0/3 (0%)		5/22 (22.7%)
Tremor	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Psychiatric disorders
Anxiety	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Insomnia	2/6 (33.3%)		1/7 (14.3%)		4/15 (26.7%)		2/23 (8.7%)		0/3 (0%)		1/22 (4.5%)
Renal and urinary disorders
Dysuria	1/6 (16.7%)		1/7 (14.3%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Urinary retention	0/6 (0%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		1/3 (33.3%)		0/22 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/6 (0%)		0/7 (0%)		2/15 (13.3%)		3/23 (13%)		0/3 (0%)		4/22 (18.2%)
Dyspnoea	0/6 (0%)		0/7 (0%)		0/15 (0%)		3/23 (13%)		0/3 (0%)		2/22 (9.1%)
Epistaxis	1/6 (16.7%)		2/7 (28.6%)		2/15 (13.3%)		2/23 (8.7%)		1/3 (33.3%)		0/22 (0%)
Hiccups	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Nasal oedema	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Oropharyngeal pain	1/6 (16.7%)		1/7 (14.3%)		0/15 (0%)		1/23 (4.3%)		0/3 (0%)		1/22 (4.5%)
Productive cough	0/6 (0%)		0/7 (0%)		0/15 (0%)		4/23 (17.4%)		0/3 (0%)		2/22 (9.1%)
Pulmonary embolism	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Rhinorrhoea	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		1/22 (4.5%)
Skin and subcutaneous tissue disorders
Acne	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		0/23 (0%)		0/3 (0%)		1/22 (4.5%)
Alopecia	2/6 (33.3%)		1/7 (14.3%)		2/15 (13.3%)		1/23 (4.3%)		1/3 (33.3%)		1/22 (4.5%)
Dry skin	1/6 (16.7%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Hyperhidrosis	0/6 (0%)		0/7 (0%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Palmar-plantar erythrodysaesthesia syndrome	0/6 (0%)		0/7 (0%)		4/15 (26.7%)		8/23 (34.8%)		1/3 (33.3%)		4/22 (18.2%)
Rash	2/6 (33.3%)		0/7 (0%)		1/15 (6.7%)		2/23 (8.7%)		0/3 (0%)		3/22 (13.6%)
Skin lesion	0/6 (0%)		1/7 (14.3%)		2/15 (13.3%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Urticaria	1/6 (16.7%)		1/7 (14.3%)		0/15 (0%)		2/23 (8.7%)		0/3 (0%)		0/22 (0%)
Skin discolouration	0/6 (0%)		0/7 (0%)		0/15 (0%)		0/23 (0%)		1/3 (33.3%)		0/22 (0%)
Vascular disorders
Flushing	0/6 (0%)		0/7 (0%)		1/15 (6.7%)		1/23 (4.3%)		0/3 (0%)		0/22 (0%)
Haematoma	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)
Hypertension	1/6 (16.7%)		1/7 (14.3%)		1/15 (6.7%)		2/23 (8.7%)		1/3 (33.3%)		1/22 (4.5%)
Hypotension	0/6 (0%)		1/7 (14.3%)		0/15 (0%)		0/23 (0%)		0/3 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.