A Phase II Study of GSK1363089 (Formerly XL880) for Papillary Renal-Cell Carcinoma (PRC)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00726323
• Collaborator: (none)
• Enrollment: 74
• Locations: 12
• Arms: 2
• Actual Duration (Months): 49.6
• Patients Per Site: 6.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This clinical study is being conducted at multiple sites to determine the best confirmed response rate, safety, and tolerability of GSK1363089 treatment in papillary renal cell carcinoma. Papillary renal cell carcinoma may be classified into hereditary and sporadic forms; subjects with either classification will be accepted into this study.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: foretinib (formerly GSK1363089 or XL880)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of the c-MET RTK Inhibitor XL880 in Subjects With Papillary Renal-Cell Carcinoma
• Actual Study Start Date: Jun 30, 2006
• Actual Primary Completion Date: Aug 18, 2010
• Actual Study Completion Date: Aug 18, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5/9 dosing 240 mg of foretinib on a 5 day on / 9 day off regimen every 14 days.	Drug: foretinib (formerly GSK1363089 or XL880); treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule; Other Names: GSK1363089 (formerly XL880)
Experimental: daily dosing 80 mg foretinib on a daily dosing regimen	Drug: foretinib (formerly GSK1363089 or XL880); treatment with oral foretinib on one of 2 dosing regimens: 240 mg on a 5 day on / 9 day off schedule every 14 days, or 80 mg on a daily dosing schedule; Other Names: GSK1363089 (formerly XL880)

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0 [At the end of forth year]

   Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator's assessment of the target and non target lesions.

Secondary Outcome Measures

1. Disease Stabilization Rate Over Period [Up to 4 years]

   The percentage of participants for whom the best overall response was a confirmed PR, confirmed CR, or stable disease. Exact confidence intervals were obtained using the Clopper-Pearson method. Exact confidence intervals were obtained using the Clopper-Pearson method.

2. Progression Free Survival (PFS) [At the end of forth year]

   Progression free survival is defined as the time between the date of first dose of study drug and the date of the first occurrence of either tumor progression per RECIST or clinical assessment of progression as assessed by Investigator or Death due to any cause, whichever occurs the first. For participants who did not reach an event (disease progression or death) at the time of data cutoff, PFS was censored at the date of the last available tumor measurement. For participants who did not have any post-baseline tumor assessments, PFS was right censored at Day 1. For any participants who received subsequent anticancer therapy, PFS was right censored at the date of last adequate tumor assessment on or prior to the date of anticancer initiation. For any participants, who died or progressed after an extended follow-up, PFS was censored at the date of last adequate assessment prior to the extended loss to follow-up.

3. Time to Response (TTR) Over Period [Up to 4 years]

   Time to response is the time between the date of first dose of study drug and the date of first response (for participants who had overall responses that were later confirmed as CR/PR). For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the time to response was censored at the date of the last visit. The median time to response was not estimable in either of the dosing cohorts or in the overall safety population using the Kaplan-Meier method.

4. Duration of Response (DOR) [Up to 4 years]

   Duration of response is defined as the time between the date of first response (later confirmed CR or confirmed PR) and the date of the first occurrence of one of the events as tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to any cause, disease progression as documented on the follow-up or participant status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of response was censored at the date of the last available tumor measurement.

5. Duration of Stable Disease (SD) [Up to 4 years]

   Duration of SD is defined as the time between the date of first dose of study drug and the date of the first occurrence of one of the tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to disease progression, or disease progression as documented on the follow-up participants status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of stable disease was right censored at the date of the last available tumor measurement.

6. Overall Survival [Up to 4 years]

   Overall survival, which is defined as the time between the date of first dose of study drug and the date of death (due to any cause). For participants who were alive at the time of data cutoff, duration of overall survival was right censored at the date of last contact. Duration of overall survival = date of death/censoring - date of first dose +1. Percentiles and confidence intervals are calculated using Kaplan-Meier methods.

7. Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period [Up to 4 years]

   The worst case overall common terminology criteria for adverse events (CTCAE) grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases (ALT), aspartate aminotransferases (AST), Albumin, alkaline phosphatase (ALP), calcium, sodium, potassium, glucose, amylase, carbon dioxide, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. High (H) levels and low (L) levels were measured.

8. Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case) [Up to 4 years]

   CTCAE gradation The worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for hemoglobin, leukocytes, platelets, percentage of lymphocytes, and percentage of neutrophils.

9. Number of Participants With Adverse Events, Serious Adverse Events, and Deaths [Up to 4 years]

   Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Histologically confirmed diagnosis of PRC with metastatic disease or bilateral multifocal renal tumors localized to kidneys. Measurable disease, ECOG performance status of </= 2.

• Adequate bone marrow reserve, hepatic, renal, and cardiovascular function.

Exclusion Criteria:

• Radiation to >/=25% of bone marrow within 14 days of GSK1363089, more than 1 prior anti-cancer therapy, received prior treatment with a c-met inhibitor, brain metastases,

• Any uncontrolled intercurrent illness,

• Pregnant or breastfeeding,

• HIV positive

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Greenbrae	California	United States	94904-2007
2	GSK Investigational Site	San Francisco	California	United States	94115
3	GSK Investigational Site	Stanford	California	United States	94305
4	GSK Investigational Site	Indianapolis	Indiana	United States	46202
5	GSK Investigational Site	Bethesda	Maryland	United States	20892
6	GSK Investigational Site	Boston	Massachusetts	United States	02115
7	GSK Investigational Site	Detroit	Michigan	United States	48201
8	GSK Investigational Site	New Brunswick	New Jersey	United States	08901
9	GSK Investigational Site	Cleveland	Ohio	United States	44195
10	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19104
11	GSK Investigational Site	Nashville	Tennessee	United States	37232
12	GSK Investigational Site	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Choueiri TK, Vaishampayan U, Rosenberg JE, Logan TF, Harzstark AL, Bukowski RM, Rini BI, Srinivas S, Stein MN, Adams LM, Ottesen LH, Laubscher KH, Sherman L, McDermott DF, Haas NB, Flaherty KT, Ross R, Eisenberg P, Meltzer PS, Merino MJ, Bottaro DP, Linehan WM, Srinivasan R. Phase II and biomarker study of the dual MET/VEGFR2 inhibitor foretinib in patients with papillary renal cell carcinoma. J Clin Oncol. 2013 Jan 10;31(2):181-6. doi: 10.1200/JCO.2012.43.3383. Epub 2012 Dec 3.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00726323
• Other Study ID Numbers: MET111644; NCT00345423
• First Posted: Jul 31, 2008
• Last Update Posted: Dec 11, 2017
• Last Verified: Sep 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: c-Met; Papillary Renal Cell Carcinoma(PRC); Sporadic papillary renal cell carcinoma,; Clear cell renal carcinoma; Hereditary papillary renal cell carcinoma,
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell

Study Results

Participant Flow

Recruitment Details	This study was conducted from 30 June 2006 till 18 August 2010 across 10 centers in the United States (US). A total of 60 participants with papillary renal-cell carcinoma (PRC) were planned to be enrolled.
Pre-assignment Detail	A total of 74 participants with PRC were enrolled in the study.

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 milligrams (mg) on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Period Title: Overall Study
STARTED	37	37
COMPLETED	0	6
NOT COMPLETED	37	31

Baseline Characteristics

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen	Total
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Total of all reporting groups
Overall Participants	37	37	74
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	55.1 (11.84)	56.2 (14.32)	55.6 (13.06)
Sex: Female, Male (Count of Participants)
Female	7 18.9%	8 21.6%	15 20.3%
Male	30 81.1%	29 78.4%	59 79.7%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 2.7%	1 2.7%	2 2.7%
Black or African American	2 5.4%	3 8.1%	5 6.8%
White	32 86.5%	32 86.5%	64 86.5%
Multiple	0 0%	1 2.7%	1 1.4%
Other	1 2.7%	0 0%	1 1.4%
Unknown	1 2.7%	0 0%	1 1.4%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Version 1.0
Description	Overall response rate is the percentage of participants for whom the best overall response to the study drug was a confirmed partial response (PR) or confirmed complete response (CR). Best overall response and its associated confirmation criteria, RECIST; Version 1.0) was based on the Investigator's assessment of the target and non target lesions.
Time Frame	At the end of forth year

Outcome Measure Data

Analysis Population Description

The Safety population included all participants who passed the screening criteria, were enrolled in the study and received at least one dose of the study drug.

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	37	37
Number (95% Confidence Interval) [Percentage of participants]	13.5 36.5%	13.5 36.5%

2. Secondary Outcome

Title	Disease Stabilization Rate Over Period
Description	The percentage of participants for whom the best overall response was a confirmed PR, confirmed CR, or stable disease. Exact confidence intervals were obtained using the Clopper-Pearson method. Exact confidence intervals were obtained using the Clopper-Pearson method.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	37	37
Number (95% Confidence Interval) [Percentage of participants]	91.9 248.4%	83.8 226.5%

3. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	Progression free survival is defined as the time between the date of first dose of study drug and the date of the first occurrence of either tumor progression per RECIST or clinical assessment of progression as assessed by Investigator or Death due to any cause, whichever occurs the first. For participants who did not reach an event (disease progression or death) at the time of data cutoff, PFS was censored at the date of the last available tumor measurement. For participants who did not have any post-baseline tumor assessments, PFS was right censored at Day 1. For any participants who received subsequent anticancer therapy, PFS was right censored at the date of last adequate tumor assessment on or prior to the date of anticancer initiation. For any participants, who died or progressed after an extended follow-up, PFS was censored at the date of last adequate assessment prior to the extended loss to follow-up.
Time Frame	At the end of forth year

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	37	37
Median (95% Confidence Interval) [Months]	11.56	9.07

4. Secondary Outcome

Title	Time to Response (TTR) Over Period
Description	Time to response is the time between the date of first dose of study drug and the date of first response (for participants who had overall responses that were later confirmed as CR/PR). For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the time to response was censored at the date of the last visit. The median time to response was not estimable in either of the dosing cohorts or in the overall safety population using the Kaplan-Meier method.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	37	37
Median (95% Confidence Interval) [Months]	NA	NA

5. Secondary Outcome

Title	Duration of Response (DOR)
Description	Duration of response is defined as the time between the date of first response (later confirmed CR or confirmed PR) and the date of the first occurrence of one of the events as tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to any cause, disease progression as documented on the follow-up or participant status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of response was censored at the date of the last available tumor measurement.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

Safety Population- All Objective Responders (those who did not reach an event by the time of data cut-off as defined in protocol)

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	5	5
Median (95% Confidence Interval) [Months]	20.50	18.46

6. Secondary Outcome

Title	Duration of Stable Disease (SD)
Description	Duration of SD is defined as the time between the date of first dose of study drug and the date of the first occurrence of one of the tumor progression per RECIST as assessed by Investigator, termination of the study drug due to disease progression, death due to disease progression, or disease progression as documented on the follow-up participants status form Initiation of subsequent anticancer therapy. For the 6 participants in the daily dosing cohort who did not reach a response as of data cutoff, the duration of stable disease was right censored at the date of the last available tumor measurement.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population. All participants with Best overall response, not progressive disease were considered.

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	34	31
Median (95% Confidence Interval) [Months]	12.88	9.26

7. Secondary Outcome

Title	Overall Survival
Description	Overall survival, which is defined as the time between the date of first dose of study drug and the date of death (due to any cause). For participants who were alive at the time of data cutoff, duration of overall survival was right censored at the date of last contact. Duration of overall survival = date of death/censoring - date of first dose +1. Percentiles and confidence intervals are calculated using Kaplan-Meier methods.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	37	37
Median (95% Confidence Interval) [Months]	NA	NA

8. Secondary Outcome

Title	Number of Participants With Change in Common Terminology Criteria for Adverse Events (CTCAE) Grade of Clinical Chemistry Parameters Over Period
Description	The worst case overall common terminology criteria for adverse events (CTCAE) grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Analysis was done for Alanine aminotransferases (ALT), aspartate aminotransferases (AST), Albumin, alkaline phosphatase (ALP), calcium, sodium, potassium, glucose, amylase, carbon dioxide, phosphate, gamma glutamyl transferases (GGT), and triglycerol lipase. High (H) levels and low (L) levels were measured.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	37	37
ALT, Grade 0 to 1	24 64.9%	21 56.8%
ALT, Grade 0 to 2	4 10.8%	1 2.7%
ALT, Grade 0 to 3	0 0%	1 2.7%
ALT, Grade 1 to 2	1 2.7%	2 5.4%
Albumin, Grade 0 to 1	9 24.3%	12 32.4%
Albumin, Grade 0 to 2	8 21.6%	11 29.7%
Albumin, Grade 0 to 3	1 2.7%	2 5.4%
Albumin, Grade 1 to 2	6 16.2%	5 13.5%
Albumin, Grade 1 to 3	0 0%	1 2.7%
ALP, Grade 0 to 1	12 32.4%	16 43.2%
ALP, Grade 0 to 2	1 2.7%	0 0%
ALP, Grade 0 to 3	0 0%	0 0%
ALP, Grade 0 to 4	0 0%	0 0%
ALP, Grade 1 to 2	0 0%	2 5.4%
Amylase, Grade 0 to 1	9 24.3%	6 16.2%
Amylase, Grade 0 to 2	1 2.7%	2 5.4%
Amylase, Grade 0 to 3	1 2.7%	1 2.7%
Amylase, Grade 1 to 2	0 0%	1 2.7%
Amylase, Grade 2 to 3	1 2.7%	0 0%
AST, Grade 0 to 1	23 62.2%	27 73%
AST, Grade 0 to 2	8 21.6%	3 8.1%
AST, Grade 0 to 3	0 0%	1 2.7%
AST, Grade 1 to 2	2 5.4%	0 0%
AST, Grade 2 to 3	1 2.7%	0 0%
Blilirubin, Grade 0 to 1	7 18.9%	1 2.7%
Blilirubin, Grade 0 to 3	1 2.7%	0 0%
Blilirubin, Grade 1 to 2	1 2.7%	0 0%
Carbon di oxide, Grade 0 to 1	11 29.7%	9 24.3%
Creatinine, Grade 0 to 1	6 16.2%	11 29.7%
Creatinine, Grade 0 to 2	3 8.1%	0 0%
Creatinine, Grade 0 to 3	2 5.4%	0 0%
Creatinine, Grade 1 to 0	1 2.7%	0 0%
Creatinine, Grade 1 to 2	2 5.4%	8 21.6%
GGT, Grade 0 to 1	7 18.9%	6 16.2%
GGT, Grade 1 to 0	0 0%	0 0%
GGT, Grade 2 to 0	0 0%
GGT, Grade 2 to 1	0 0%
Phosphate, Grade 0 to 1	1 2.7%	1 2.7%
Phosphate, Grade 0 to 2	8 21.6%	10 27%
Phosphate, Grade 0 to 3	13 35.1%	8 21.6%
Phosphate, Grade 2 to 0	0 0%	1 2.7%
Phosphate, Grade 2 to 3	0 0%	1 2.7%
Phosphate, Grade 2 to 4	1 2.7%	0 0%
Triglycerol lipase, Grade 0 to 1	6 16.2%	9 24.3%
Triglycerol lipase, Grade 0 to 2	1 2.7%	6 16.2%
Triglycerol lipase, Grade 0 to 3	4 10.8%	4 10.8%
Triglycerol lipase, Grade 0 to 4	0 0%	1 2.7%
Triglycerol lipase, Grade 1 to 3	1 2.7%	1 2.7%
Triglycerol lipase, Grade 1 to 4	1 2.7%	0 0%
Triglycerol lipase, Grade 2 to 3	1 2.7%
Calcium, L, Grade 0 to 1	12 32.4%	14 37.8%
Calcium, L, Grade 0 to 2	7 18.9%	13 35.1%
Calcium, L, Grade 0 to 3	1 2.7%	2 5.4%
Glucose, L, Grade 0 to 1	10 27%	11 29.7%
Glucose, L, Grade 0 to 2	1 2.7%	4 10.8%
Glucose, L, Grade 0 to 3	0 0%	1 2.7%
Glucose, L, Grade 1 to 3	0 0%	1 2.7%
Potassium, L, Grade 0 to 1	5 13.5%	2 5.4%
Potassium, L, Grade 1 to 0	1 2.7%
Sodium, L, Grade 0 to 1	11 29.7%	14 37.8%
Sodium, L, Grade 0 to 3	3 8.1%	6 16.2%
Sodium, L, Grade 1 to 3	1 2.7%
Calcium, H, Grade 0 to 1	2 5.4%	0 0%
Glucose, H, Grade 0 to 1	16 43.2%	10 27%
Glucose, H, Grade 0 to 2	6 16.2%	4 10.8%
Glucose, H, Grade 1 to 0	0 0%	1 2.7%
Glucose, H, Grade 1 to 2	4 10.8%	2 5.4%
Glucose, H, Grade 1 to 3	1 2.7%	0 0%
Glucose, H, Grade 2 to 3	1 2.7%
Potassium, H, Grade 0 to 1	5 13.5%	11 29.7%
Potassium, H, Grade 0 to 2	8 21.6%	6 16.2%
Potaasium, H, Grade 0 to 3	0 0%	1 2.7%
Potassium, H, Grade 1 to 3	1 2.7%
Sodium, H, Grade 0 to 1	6 16.2%	7 18.9%
Sodium, H, Grade 1 to 0	1 2.7%

9. Secondary Outcome

Title	Number of Participants With Change in CTCAE Grade of Hematological Parameters Over Period (Only Worst Case)
Description	CTCAE gradation The worst case overall CTCAE grade shift post Baseline for each parameter was mentioned. Only worst case scenarios are presented. CTCAE grading was done as per intensity namely mild moderate severe life-threatening or Death. Participants were analyzed for hemoglobin, leukocytes, platelets, percentage of lymphocytes, and percentage of neutrophils.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	37	37
Hemoglobin, Grade 0 to 1	12 32.4%	7 18.9%
Hemoglobin, Grade 0 to 2	1 2.7%	0 0%
Hemoglobin, Grade 1 to 2	3 8.1%	2 5.4%
Hemoglobin, Grade 1 to 3	1 2.7%	1 2.7%
Hemoglobin, Grade 2 to 1	1 2.7%	1 2.7%
Leukocytes, Grade 0 to 1	5 13.5%	10 27%
Leukocytes, Grade 0 to 2	2 5.4%	0 0%
Leukocytes, Grade 1 to 2	1 2.7%
Leukocytes, Grade 2 to 0	1 2.7%
Percentage lymphocytes, Grade 0 to 1	5 13.5%	8 21.6%
Percentage lymphocytes, Grade 0 to 2	4 10.8%	0 0%
Percentage lymphocytes, Grade 0 to 3	3 8.1%	2 5.4%
Percentage lymphocytes, Grade 1 to 0	0 0%	1 2.7%
Percentage lymphocytes, Grade 1 to 2	1 2.7%	2 5.4%
Percentage lymphocytes, Grade 2 to 0	1 2.7%	0 0%
Percentage lymphocytes, Grade 2 to 1	0 0%	1 2.7%
Percentage lymphocytes, Grade 2 to 3	3 8.1%	0 0%
Percentage lymphocytes, Grade 3 to 4	1 2.7%
Percentage neutrophils, Grade 0 to 1	4 10.8%	4 10.8%
Percentage neutrophils, Grade 0 to 2	1 2.7%	1 2.7%
Percentage neutrophils, Grade 0 to 4	0 0%	1 2.7%
Percentage neutrophils, Grade 1 to 0	1 2.7%	0 0%
Platelets, Grade 0 to 1	12 32.4%	18 48.6%
Platelets, Grade 0 to 2	1 2.7%	2 5.4%
Platelets, Grade 1 to 2	1 2.7%

10. Secondary Outcome

Title	Number of Participants With Adverse Events, Serious Adverse Events, and Deaths
Description	Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
Time Frame	Up to 4 years

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	Intermittent 5 & 9 Dosing Regimen	Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.	Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up up to 8 weeks after the last dose of the study drug for tumor assessment.
Measure Participants	37	37
Any AE	37 100%	37 100%
Any SAE	20 54.1%	22 59.5%
Death	14 37.8%	6 16.2%

Adverse Events

Time Frame	Approximately up to 48 months
Adverse Event Reporting Description	The Safety population included all participants who passed the screening criteria, are enrolled in the study and received at least one dose of the study drug.
Arm/Group Title	Intermittent 5 & 9 Dosing Regimen		Daily Dosing Regimen
Arm/Group Description	Eligible participants received oral foretinib bisphosphate 240 mg on Days 1 to 5 of every 14-day cycle. Participants continued this schedule for 8 weeks. The treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up every 8 weeks for tumor assessment, while the participant remained in the treatment extension period.		Eligible participants received oral foretinib bisphosphate 80 mg daily of every 14-day cycle. Participants continued this schedule for 8 weeks. treatment drug was supposed to be stopped any time in case of disease progression. All participants were followed-up every 8 weeks for tumor assessment, while the participant remained in the treatment extension period.
All Cause Mortality
	Intermittent 5 & 9 Dosing Regimen		Daily Dosing Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/37 (37.8%)		6/37 (16.2%)
Serious Adverse Events
	Intermittent 5 & 9 Dosing Regimen		Daily Dosing Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/37 (54.1%)		22/37 (59.5%)
Blood and lymphatic system disorders
Thrombocytopenia	0/37 (0%)		1/37 (2.7%)
Thrombotic microangiopathy	0/37 (0%)		1/37 (2.7%)
Cardiac disorders
Angina pectoris	1/37 (2.7%)		0/37 (0%)
Atrial fibrillation	0/37 (0%)		1/37 (2.7%)
Atrial flutter	1/37 (2.7%)		0/37 (0%)
Cardiac failure congestive	0/37 (0%)		1/37 (2.7%)
Left ventricular dysfunction	0/37 (0%)		1/37 (2.7%)
Myocardial ischaemia	0/37 (0%)		1/37 (2.7%)
Ventricular fibrillation	1/37 (2.7%)		0/37 (0%)
Congenital, familial and genetic disorders
Colour blindness	0/37 (0%)		1/37 (2.7%)
Eye disorders
Diplopia	0/37 (0%)		2/37 (5.4%)
Night blindness	4/37 (10.8%)		4/37 (10.8%)
Optic ischaemic neuropathy	0/37 (0%)		1/37 (2.7%)
Retinal vein occlusion	1/37 (2.7%)		0/37 (0%)
Vision blurred	0/37 (0%)		1/37 (2.7%)
Visual impairment	0/37 (0%)		1/37 (2.7%)
Vitreous haemorrhage	1/37 (2.7%)		0/37 (0%)
Gastrointestinal disorders
Abdominal distension	1/37 (2.7%)		0/37 (0%)
Abdominal pain	1/37 (2.7%)		1/37 (2.7%)
Diarrhoea	2/37 (5.4%)		1/37 (2.7%)
Nausea	0/37 (0%)		1/37 (2.7%)
Vomiting	1/37 (2.7%)		1/37 (2.7%)
General disorders
Disease progression	0/37 (0%)		1/37 (2.7%)
Oedema peripheral	1/37 (2.7%)		0/37 (0%)
Infections and infestations
Infection	1/37 (2.7%)		0/37 (0%)
Lung infection	0/37 (0%)		1/37 (2.7%)
Peridiverticular abscess	1/37 (2.7%)		0/37 (0%)
Pneumonia	0/37 (0%)		1/37 (2.7%)
Sepsis	1/37 (2.7%)		0/37 (0%)
Injury, poisoning and procedural complications
Wound complication	1/37 (2.7%)		0/37 (0%)
Investigations
Alanine aminotransferase increased	0/37 (0%)		1/37 (2.7%)
Blood creatinine increased	1/37 (2.7%)		0/37 (0%)
Lipase increased	1/37 (2.7%)		0/37 (0%)
Metabolism and nutrition disorders
Dehydration	2/37 (5.4%)		0/37 (0%)
Hypoglycaemia	0/37 (0%)		1/37 (2.7%)
Hyponatraemia	1/37 (2.7%)		0/37 (0%)
Hypophosphataemia	1/37 (2.7%)		0/37 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/37 (2.7%)		0/37 (0%)
Musculoskeletal pain	1/37 (2.7%)		0/37 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer	2/37 (5.4%)		1/37 (2.7%)
Nervous system disorders
Cerebral haemorrhage	0/37 (0%)		1/37 (2.7%)
Cerebral microhaemorrhage	1/37 (2.7%)		0/37 (0%)
Visual field defect	0/37 (0%)		1/37 (2.7%)
Psychiatric disorders
Confusional state	1/37 (2.7%)		2/37 (5.4%)
Suicidal ideation	1/37 (2.7%)		0/37 (0%)
Renal and urinary disorders
Proteinuria	1/37 (2.7%)		2/37 (5.4%)
Renal failure	0/37 (0%)		1/37 (2.7%)
Renal failure acute	1/37 (2.7%)		0/37 (0%)
Renal haemorrhage	1/37 (2.7%)		0/37 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchospasm	0/37 (0%)		1/37 (2.7%)
Cough	0/37 (0%)		1/37 (2.7%)
Dyspnoea	1/37 (2.7%)		2/37 (5.4%)
Haemoptysis	0/37 (0%)		1/37 (2.7%)
Obstructive airways disorder	0/37 (0%)		1/37 (2.7%)
Pleural effusion	2/37 (5.4%)		0/37 (0%)
Pulmonary embolism	4/37 (10.8%)		4/37 (10.8%)
Vascular disorders
Deep vein thrombosis	2/37 (5.4%)		1/37 (2.7%)
Hypertension	1/37 (2.7%)		0/37 (0%)
Hypertensive crisis	1/37 (2.7%)		0/37 (0%)
Jugular vein thrombosis	0/37 (0%)		1/37 (2.7%)
Other (Not Including Serious) Adverse Events
	Intermittent 5 & 9 Dosing Regimen		Daily Dosing Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/37 (100%)		37/37 (100%)
Blood and lymphatic system disorders
Thrombocytopenia	3/37 (8.1%)		5/37 (13.5%)
Anaemia	2/37 (5.4%)		1/37 (2.7%)
Cardiac disorders
Atrial fibrillation	2/37 (5.4%)		1/37 (2.7%)
Endocrine disorders
Hypothyroidism	4/37 (10.8%)		9/37 (24.3%)
Adrenal insufficiency	0/37 (0%)		3/37 (8.1%)
Eye disorders
Periorbital oedema	3/37 (8.1%)		0/37 (0%)
Eye pain	2/37 (5.4%)		0/37 (0%)
Gastrointestinal disorders
Diarrhoea	21/37 (56.8%)		29/37 (78.4%)
Nausea	28/37 (75.7%)		19/37 (51.4%)
Vomiting	22/37 (59.5%)		13/37 (35.1%)
Constipation	14/37 (37.8%)		11/37 (29.7%)
Flatulence	9/37 (24.3%)		5/37 (13.5%)
Abdominal pain	6/37 (16.2%)		6/37 (16.2%)
Dyspepsia	6/37 (16.2%)		5/37 (13.5%)
Dry mouth	5/37 (13.5%)		3/37 (8.1%)
Abdominal distension	4/37 (10.8%)		3/37 (8.1%)
Abdominal pain upper	6/37 (16.2%)		1/37 (2.7%)
Gastrooesophageal reflux disease	2/37 (5.4%)		5/37 (13.5%)
Abdominal pain lower	2/37 (5.4%)		2/37 (5.4%)
Ascites	1/37 (2.7%)		3/37 (8.1%)
Glossodynia	2/37 (5.4%)		1/37 (2.7%)
Haemorrhoids	3/37 (8.1%)		0/37 (0%)
Stomatiti	3/37 (8.1%)		0/37 (0%)
Abdominal discomfort	0/37 (0%)		2/37 (5.4%)
General disorders
Fatigue	31/37 (83.8%)		27/37 (73%)
Oedema peripheral	11/37 (29.7%)		17/37 (45.9%)
Chills	7/37 (18.9%)		0/37 (0%)
Localised oedema	2/37 (5.4%)		2/37 (5.4%)
Pyrexia	4/37 (10.8%)		0/37 (0%)
Early satiety	2/37 (5.4%)		1/37 (2.7%)
Pain	2/37 (5.4%)		1/37 (2.7%)
Mucosal inflammation	2/37 (5.4%)		0/37 (0%)
Non-cardiac chest pain	2/37 (5.4%)		0/37 (0%)
Temperature intolerance	0/37 (0%)		2/37 (5.4%)
Infections and infestations
Upper respiratory tract infection	6/37 (16.2%)		7/37 (18.9%)
Sinusitis	2/37 (5.4%)		7/37 (18.9%)
Urinary tract infection	2/37 (5.4%)		2/37 (5.4%)
Rhinitis	3/37 (8.1%)		0/37 (0%)
Viral infection	2/37 (5.4%)		1/37 (2.7%)
Ear infection	2/37 (5.4%)		0/37 (0%)
Influenza	2/37 (5.4%)		0/37 (0%)
Injury, poisoning and procedural complications
Contusion	3/37 (8.1%)		3/37 (8.1%)
Excoriation	0/37 (0%)		2/37 (5.4%)
Thermal burn	2/37 (5.4%)		0/37 (0%)
Investigations
Blood creatinine increased	9/37 (24.3%)		6/37 (16.2%)
Aspartate aminotransferase increased	10/37 (27%)		4/37 (10.8%)
Lipase increased	7/37 (18.9%)		7/37 (18.9%)
Weight decreased	6/37 (16.2%)		8/37 (21.6%)
Alanine aminotransferase increased	9/37 (24.3%)		4/37 (10.8%)
Blood amylase increased	5/37 (13.5%)		2/37 (5.4%)
Blood lactate dehydrogenase increased	4/37 (10.8%)		3/37 (8.1%)
Electrocardiogram QT prolonged	0/37 (0%)		5/37 (13.5%)
Blood urea increased	3/37 (8.1%)		0/37 (0%)
Blood alkaline phosphatase increased	2/37 (5.4%)		0/37 (0%)
Blood bilirubin increased	2/37 (5.4%)		0/37 (0%)
Blood thyroid stimulating hormone increased	2/37 (5.4%)		0/37 (0%)
Gamma-glutamyltransferase increased	2/37 (5.4%)		0/37 (0%)
Metabolism and nutrition disorders
Decreased appetite	18/37 (48.6%)		14/37 (37.8%)
Hypophosphataemia	11/37 (29.7%)		13/37 (35.1%)
Hyperkalaemia	6/37 (16.2%)		5/37 (13.5%)
Hypoalbuminaemia	3/37 (8.1%)		5/37 (13.5%)
Dehydration	4/37 (10.8%)		3/37 (8.1%)
Hyponatraemia	2/37 (5.4%)		5/37 (13.5%)
Hypoglycaemia	1/37 (2.7%)		3/37 (8.1%)
Hypocalcaemia	0/37 (0%)		3/37 (8.1%)
Hyperuricaemia	0/37 (0%)		2/37 (5.4%)
Vitamin D deficiency	0/37 (0%)		2/37 (5.4%)
Musculoskeletal and connective tissue disorders
Back pain	9/37 (24.3%)		7/37 (18.9%)
Muscle spasms	8/37 (21.6%)		7/37 (18.9%)
Myalgia	9/37 (24.3%)		3/37 (8.1%)
Arthralgia	6/37 (16.2%)		5/37 (13.5%)
Musculoskeletal pain	6/37 (16.2%)		3/37 (8.1%)
Flank pain	5/37 (13.5%)		3/37 (8.1%)
Pain in extremity	3/37 (8.1%)		3/37 (8.1%)
Groin pain	2/37 (5.4%)		2/37 (5.4%)
Musculoskeletal chest pain	3/37 (8.1%)		1/37 (2.7%)
Muscular weakness	2/37 (5.4%)		1/37 (2.7%)
Pain in jaw	2/37 (5.4%)		1/37 (2.7%)
Joint swelling	2/37 (5.4%)		0/37 (0%)
Nervous system disorders
Headache	17/37 (45.9%)		8/37 (21.6%)
Dizziness	9/37 (24.3%)		5/37 (13.5%)
Dysgeusia	4/37 (10.8%)		5/37 (13.5%)
Peripheral sensory neuropathy	3/37 (8.1%)		2/37 (5.4%)
Cranial nerve disorder	2/37 (5.4%)		0/37 (0%)
Neuropathy peripheral	0/37 (0%)		2/37 (5.4%)
Paraesthesia	2/37 (5.4%)		0/37 (0%)
Peripheral motor neuropathy	2/37 (5.4%)		0/37 (0%)
Psychiatric disorders
Anxiety	2/37 (5.4%)		5/37 (13.5%)
Insomnia	4/37 (10.8%)		3/37 (8.1%)
Depression	2/37 (5.4%)		3/37 (8.1%)
Confusional state	3/37 (8.1%)		1/37 (2.7%)
Renal and urinary disorders
Proteinuria	5/37 (13.5%)		8/37 (21.6%)
Pollakiuria	4/37 (10.8%)		0/37 (0%)
Haematuria	2/37 (5.4%)		1/37 (2.7%)
Nocturia	3/37 (8.1%)		0/37 (0%)
Reproductive system and breast disorders
Erectile dysfunction	1/37 (2.7%)		3/37 (8.1%)
Respiratory, thoracic and mediastinal disorders
Cough	13/37 (35.1%)		12/37 (32.4%)
Dysphonia	8/37 (21.6%)		7/37 (18.9%)
Dyspnoea	10/37 (27%)		4/37 (10.8%)
Dyspnoea exertional	2/37 (5.4%)		1/37 (2.7%)
Epistaxis	3/37 (8.1%)		0/37 (0%)
Nasal congestion	1/37 (2.7%)		2/37 (5.4%)
Oropharyngeal pain	3/37 (8.1%)		0/37 (0%)
Pleural effusion	2/37 (5.4%)		1/37 (2.7%)
Pleuritic pain	0/37 (0%)		2/37 (5.4%)
Skin and subcutaneous tissue disorders
Rash	12/37 (32.4%)		8/37 (21.6%)
Hyperhidrosis	5/37 (13.5%)		4/37 (10.8%)
Dermatitis acneiform	1/37 (2.7%)		5/37 (13.5%)
Pruritus	4/37 (10.8%)		2/37 (5.4%)
Alopecia	4/37 (10.8%)		1/37 (2.7%)
Dry skin	3/37 (8.1%)		1/37 (2.7%)
Exfoliative rash	3/37 (8.1%)		1/37 (2.7%)
Night sweats	3/37 (8.1%)		0/37 (0%)
Palmar-plantar erythrodysaesthesia syndrome	1/37 (2.7%)		2/37 (5.4%)
Vascular disorders
Hypertension	28/37 (75.7%)		34/37 (91.9%)
Flushing	2/37 (5.4%)		1/37 (2.7%)
Deep vein thrombosis	0/37 (0%)		2/37 (5.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.