Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00976508
• Collaborator: (none)
• Enrollment: 24
• Locations: 5
• Arm: 1
• Duration (Months): 35
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Sarcoma	Drug: figitumumab; Drug: pegvisomant	Phase 1

Detailed Description

This study was closed to enrollment on 18 April 2011 due to inability to recruit patients on a timely basis as well as business reasons. Study closure was not related to any safety concerns.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: figitumumab; IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year; Other Names: CP-751,871 ; Drug: pegvisomant; growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year; Other Names: Somavert

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [From Screening to the follow-up visit (90 days after last dose of figitimumab)]

   Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

2. Number of Participants With Dose Limiting Toxicities (DLT) [From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2]

   DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting >=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve.

Secondary Outcome Measures

1. Serum Circulating Insulin-like Growth Factor (IGF-1) Levels [Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)]

   The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.

2. Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab [Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15]

3. Maximum Observed Plasma Concentration (Cmax) of Figitumumab [Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit]

4. Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab [Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15]

5. Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab [Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit]

   Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.

6. Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab [Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.

7. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab [Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1

8. Area Under the Trough Concentrations (AUCtrough) [Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit]

   The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.

9. Mean Change in Glucose Levels Between Fasting and Post Glucose Load [Screening; Day 8 of Cycle 1; Day 15 of Cycle 2]

   The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant.

10. Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab [Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)]

    Percentage of participants with positive total or neutralizing ADA for figitumumab.

11. Number of Participants With Objective Response [From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)]

    Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients ≥18 years of age with advanced solid tumors for which the combination of figitumumab and pegvisomant are reasonable treatment options.

• Patients between the ages of 10 and 18 years with advanced sarcomas for which there is no available curative therapy or therapy proven to prolong survival with an acceptable quality of life will be included in the Sarcoma Expansion Cohort.

• Adequate recovery from prior therapies.

• Adequate organ function (i.e. bone marrow, kidney, liver)

• Total IGF-1 ≥100 ng/ml (13 nmol/L).

Exclusion Criteria:

• Concurrent treatment with any anti-tumor agents.

• Pregnant or breastfeeding females.

• Significant past history or active cardiac disease

• Active infection

• History of diabetes mellitus.

• Glycosylated hemoglobin >5.7

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55455
2	Pfizer Investigational Site	Rochester	Minnesota	United States	55905
3	Pfizer Investigational Site	Montreal	Quebec	Canada	H3T 1E2
4	Pfizer Investigational Site	Helsinki		Finland	00290
5	Pfizer Investigational Site	Muenster		Germany	48149

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: NCT00976508
• Other Study ID Numbers: A4021040
• First Posted: Sep 14, 2009
• Last Update Posted: Dec 13, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Pfizer: advanced solid tumors cancer refractory cancer figitumumab pegvisomant
• Additional relevant MeSH terms: Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms; Lung Neoplasms

Study Results

Participant Flow

Arm/Group Title	Figitumumab 20mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Period Title: Overall Study
STARTED	17	6
COMPLETED	3	0
NOT COMPLETED	14	6

Baseline Characteristics

Arm/Group Title	Figitumumab 20 mg/kg +Pegvisomant 10 mg	Figitumumab 20 mg/kg + Pegvisomant 20 mg	Total
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Total of all reporting groups
Overall Participants	17	6	23
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.5 (17.4)	32.3 (9.8)	45.0 (17.4)
Sex: Female, Male (Count of Participants)
Female	8 47.1%	5 83.3%	13 56.5%
Male	9 52.9%	1 16.7%	10 43.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade [Gr] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time Frame	From Screening to the follow-up visit (90 days after last dose of figitimumab)

Outcome Measure Data

Analysis Population Description

Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications.

Arm/Group Title	Figitumumab 20mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	17	6
Number of participants with AEs	17 100%	6 100%
Number of participants with SAEs	9 52.9%	4 66.7%
Number of participants with Gr 3 or Gr 4 AEs	12 70.6%	4 66.7%
Number of participants with Gr 5 AEs	7 41.2%	1 16.7%

2. Primary Outcome

Title	Number of Participants With Dose Limiting Toxicities (DLT)
Description	DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting >=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever >=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr >=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia >=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve.
Time Frame	From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2

Outcome Measure Data

Analysis Population Description

Safety analysis set: all enrolled participants who received at least 1 dose of either of the study medications. N=number of participants remained on treatment throughout the required DLT period and included as analyzed for DLT based on the defined DLT evaluability specifications.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	6	6
Number [participants]	1 5.9%	0 0%

3. Secondary Outcome

Title	Serum Circulating Insulin-like Growth Factor (IGF-1) Levels
Description	The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.
Time Frame	Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)

Outcome Measure Data

Analysis Population Description

Biomarker analysis set: all enrolled participants who had at least 1 baseline or on-study sample submitted. N=number of participants who were evaluable for IGF-1 Levels at prespecified time points.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	17	6
Baseline/Cycle 1 (n = 16, 6)	150.18 (77.06)	189.17 (59.79)
Cycle 2 (n = 12, 6)	725.72 (497.12)	498.50 (218.28)
Cycle 3 (n = 6, 5)	474.53 (418.39)	247.40 (147.41)
Cycle 4 (n = 5, 3)	542.09 (510.84)	124.67 (83.94)
Cycle 5 (n = 3, 4)	990.40 (542.21)	248.25 (127.43)
Cycle 6 (n = 2, 2)	1369.5 (161.93)	122.50 (137.89)
Cycle 7 (n = 1, 2)	1594.00 (NA)	272.50 (105.36)
Cycle 8 (n = 0, 2)	NA (NA)	501.00 (94.75)
Cycle 9 (n = 0, 2)	NA (NA)	331.00 (229.10)
Cycle 10 (n = 0, 2)	NA (NA)	412.50 (185.97)
Cycle 11 (n = 0, 2)	NA (NA)	426.50 (119.50)
Cycle 12 (n = 0, 2)	NA (NA)	375.50 (350.02)
Cycle 13 (n = 0, 2)	NA (NA)	457.50 (36.06)
Cycle 14 (n = 0, 2)	NA (NA)	420.00 (45.25)
Cycle 15 (n = 0, 2)	NA (NA)	444.50 (47.38)
Cycle 16 (n = 0, 2)	NA (NA)	443.50 (23.33)
Cycle 17 (n = 0, 2)	NA (NA)	426.00 (4.24)
Cycle 18 (n = 0, 2)	NA (NA)	570.50 (487.20)
Cycle 19 (n = 0, 1)	NA (NA)	537.00 (NA)
Cycle 20 (n = 0, 2)	NA (NA)	458.50 (239.71)
Cycle 21 (n = 0, 2)	NA (NA)	437.00 (21.21)
Cycle 22 (n = 0, 1)	NA (NA)	401.00 (NA)
Cycle 23 (n = 0, 1)	NA (NA)	481.00 (NA)
Cycle 24 (n = 0, 1)	NA (NA)	361.00 (NA)
Cycle 25 (n = 0, 1)	NA (NA)	424.00 (NA)
Cycle 26 (n = 0, 1)	NA (NA)	366.00 (NA)
Cycle 27 (n = 0, 0)	NA (NA)	NA (NA)
Follow-Up (n = 2, 1)	791.50 (813.88)	1285.00 (NA)

4. Secondary Outcome

Title	Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Time Frame	Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	0	0

5. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Time Frame	Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit

Outcome Measure Data

Analysis Population Description

PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	0	0

6. Secondary Outcome

Title	Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab
Time Frame	Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15

Outcome Measure Data

Analysis Population Description

PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	0	0

7. Secondary Outcome

Title	Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab
Description	Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.
Time Frame	Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit

Outcome Measure Data

Analysis Population Description

PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	0	0

8. Secondary Outcome

Title	Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.
Time Frame	Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)

Outcome Measure Data

Analysis Population Description

PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20 mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
Measure Participants	0	0

9. Secondary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1
Time Frame	Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit

Outcome Measure Data

Analysis Population Description

PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	0	0

10. Secondary Outcome

Title	Area Under the Trough Concentrations (AUCtrough)
Description	The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.
Time Frame	Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit

Outcome Measure Data

Analysis Population Description

PK samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	0	0

11. Secondary Outcome

Title	Mean Change in Glucose Levels Between Fasting and Post Glucose Load
Description	The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels. The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant.
Time Frame	Screening; Day 8 of Cycle 1; Day 15 of Cycle 2

Outcome Measure Data

Analysis Population Description

Glucose tolerance set: All enrolled participants who started treatment and who had at least one baseline or on-study sample submitted. N=number of participants with analyable data for this outcome measure.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	17	6
Screening (n = 17, 6)	30.35 (34.02)	4.67 (17.60)
Cycle 1 Day 8 (n = 15, 5)	37.68 (30.95)	15.40 (32.04)
Cycle 2 Day 15 (n = 4, 5)	55.15 (49.35)	13.40 (28.35)

12. Secondary Outcome

Title	Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
Description	Percentage of participants with positive total or neutralizing ADA for figitumumab.
Time Frame	Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)

Outcome Measure Data

Analysis Population Description

ADA samples were not analyzed as the study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	0	0

13. Secondary Outcome

Title	Number of Participants With Objective Response
Description	Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Time Frame	From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)

Outcome Measure Data

Analysis Population Description

Response-evaluable set: All participants who started Cycle 1 with an adequate baseline tumor assessment and at least 1 follow up tumor assessment.

Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg	Figitumumab 20mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
Measure Participants	17	6
Number [participants]	0 0%	3 50%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Figitumumab 20 mg/kg + Pegvisomant 10 mg		Figitumumab 20 mg/kg + Pegvisomant 20 mg
Arm/Group Description	Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.		Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
All Cause Mortality
	Figitumumab 20 mg/kg + Pegvisomant 10 mg		Figitumumab 20 mg/kg + Pegvisomant 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Figitumumab 20 mg/kg + Pegvisomant 10 mg		Figitumumab 20 mg/kg + Pegvisomant 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/17 (52.9%)		4/6 (66.7%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/17 (5.9%)		0/6 (0%)
General disorders
Death	1/17 (5.9%)		0/6 (0%)
Disease progression	4/17 (23.5%)		1/6 (16.7%)
Fatigue	1/17 (5.9%)		0/6 (0%)
General physical health deterioration	1/17 (5.9%)		0/6 (0%)
Medical device complication	0/17 (0%)		1/6 (16.7%)
Pain	0/17 (0%)		1/6 (16.7%)
Pyrexia	0/17 (0%)		1/6 (16.7%)
Infections and infestations
Pelvic infection	0/17 (0%)		1/6 (16.7%)
Investigations
Blood uric acid increased	1/17 (5.9%)		0/6 (0%)
C-reactive protein increased	0/17 (0%)		1/6 (16.7%)
Metabolism and nutrition disorders
Dehydration	0/17 (0%)		1/6 (16.7%)
Musculoskeletal and connective tissue disorders
Back pain	1/17 (5.9%)		0/6 (0%)
Flank pain	1/17 (5.9%)		0/6 (0%)
Nervous system disorders
Cauda equina syndrome	1/17 (5.9%)		0/6 (0%)
Headache	1/17 (5.9%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumonitis	0/17 (0%)		1/6 (16.7%)
Other (Not Including Serious) Adverse Events
	Figitumumab 20 mg/kg + Pegvisomant 10 mg		Figitumumab 20 mg/kg + Pegvisomant 20 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/17 (100%)		6/6 (100%)
Blood and lymphatic system disorders
Anaemia	1/17 (5.9%)		2/6 (33.3%)
Lymphadenopathy	1/17 (5.9%)		0/6 (0%)
Neutropenia	1/17 (5.9%)		0/6 (0%)
Thrombocytopenia	1/17 (5.9%)		0/6 (0%)
Cardiac disorders
Tachycardia	0/17 (0%)		1/6 (16.7%)
Ear and labyrinth disorders
Ear discomfort	1/17 (5.9%)		2/6 (33.3%)
Hearing impaired	0/17 (0%)		1/6 (16.7%)
Sudden hearing loss	1/17 (5.9%)		0/6 (0%)
Eye disorders
Dry eye	1/17 (5.9%)		1/6 (16.7%)
Ocular hyperaemia	0/17 (0%)		1/6 (16.7%)
Gastrointestinal disorders
Abdominal discomfort	1/17 (5.9%)		0/6 (0%)
Abdominal distension	1/17 (5.9%)		1/6 (16.7%)
Abdominal pain	2/17 (11.8%)		0/6 (0%)
Abdominal pain lower	1/17 (5.9%)		0/6 (0%)
Abdominal pain upper	0/17 (0%)		2/6 (33.3%)
Constipation	5/17 (29.4%)		2/6 (33.3%)
Diarrhoea	7/17 (41.2%)		4/6 (66.7%)
Dry mouth	3/17 (17.6%)		0/6 (0%)
Dyspepsia	2/17 (11.8%)		3/6 (50%)
Dysphagia	0/17 (0%)		2/6 (33.3%)
Erosive oesophagitis	1/17 (5.9%)		0/6 (0%)
Eructation	1/17 (5.9%)		0/6 (0%)
Flatulence	2/17 (11.8%)		0/6 (0%)
Gastric ulcer	1/17 (5.9%)		0/6 (0%)
Gastritis	1/17 (5.9%)		1/6 (16.7%)
Gastrooesophageal reflux disease	1/17 (5.9%)		0/6 (0%)
Hiatus hernia	0/17 (0%)		1/6 (16.7%)
Impaired gastric emptying	0/17 (0%)		1/6 (16.7%)
Nausea	9/17 (52.9%)		2/6 (33.3%)
Proctalgia	0/17 (0%)		1/6 (16.7%)
Rectal haemorrhage	0/17 (0%)		1/6 (16.7%)
Stomatitis	1/17 (5.9%)		0/6 (0%)
Vomiting	4/17 (23.5%)		1/6 (16.7%)
General disorders
Asthenia	1/17 (5.9%)		0/6 (0%)
Chest pain	2/17 (11.8%)		2/6 (33.3%)
Chills	2/17 (11.8%)		0/6 (0%)
Disease progression	2/17 (11.8%)		0/6 (0%)
Exercise tolerance decreased	1/17 (5.9%)		0/6 (0%)
Fatigue	13/17 (76.5%)		4/6 (66.7%)
General physical health deterioration	0/17 (0%)		1/6 (16.7%)
Injection site induration	1/17 (5.9%)		0/6 (0%)
Injection site reaction	1/17 (5.9%)		0/6 (0%)
Medical device pain	0/17 (0%)		1/6 (16.7%)
Mucosal inflammation	0/17 (0%)		1/6 (16.7%)
Necrosis	0/17 (0%)		1/6 (16.7%)
Oedema peripheral	2/17 (11.8%)		1/6 (16.7%)
Pain	2/17 (11.8%)		1/6 (16.7%)
Pyrexia	1/17 (5.9%)		1/6 (16.7%)
Thirst	1/17 (5.9%)		0/6 (0%)
Hepatobiliary disorders
Cholangitis	0/17 (0%)		1/6 (16.7%)
Immune system disorders
Contrast media allergy	0/17 (0%)		1/6 (16.7%)
Infections and infestations
Fungal infection	0/17 (0%)		1/6 (16.7%)
Lung infection	1/17 (5.9%)		1/6 (16.7%)
Nasopharyngitis	1/17 (5.9%)		1/6 (16.7%)
Paronychia	0/17 (0%)		1/6 (16.7%)
Pelvic infection	0/17 (0%)		1/6 (16.7%)
Rhinitis	0/17 (0%)		2/6 (33.3%)
Sinusitis	0/17 (0%)		1/6 (16.7%)
Upper respiratory tract infection	2/17 (11.8%)		1/6 (16.7%)
Urinary tract infection	0/17 (0%)		1/6 (16.7%)
Wound infection	0/17 (0%)		1/6 (16.7%)
Injury, poisoning and procedural complications
Contusion	0/17 (0%)		1/6 (16.7%)
Fall	1/17 (5.9%)		0/6 (0%)
Procedural pain	0/17 (0%)		1/6 (16.7%)
Thermal burn	1/17 (5.9%)		0/6 (0%)
Investigations
Alanine aminotransferase increased	0/17 (0%)		1/6 (16.7%)
Aspartate aminotransferase increased	0/17 (0%)		1/6 (16.7%)
Blood albumin decreased	1/17 (5.9%)		0/6 (0%)
Blood alkaline phosphatase increased	0/17 (0%)		1/6 (16.7%)
Blood bilirubin increased	1/17 (5.9%)		0/6 (0%)
Blood creatinine increased	3/17 (17.6%)		2/6 (33.3%)
Blood uric acid increased	2/17 (11.8%)		0/6 (0%)
C-reactive protein increased	1/17 (5.9%)		1/6 (16.7%)
Gamma-glutamyltransferase increased	2/17 (11.8%)		0/6 (0%)
Haemoglobin decreased	3/17 (17.6%)		1/6 (16.7%)
Insulin-like growth factor increased	0/17 (0%)		2/6 (33.3%)
International normalised ratio increased	1/17 (5.9%)		1/6 (16.7%)
Neutrophil count decreased	0/17 (0%)		1/6 (16.7%)
Platelet count decreased	1/17 (5.9%)		0/6 (0%)
Weight decreased	3/17 (17.6%)		3/6 (50%)
Weight increased	1/17 (5.9%)		0/6 (0%)
Metabolism and nutrition disorders
Decreased appetite	9/17 (52.9%)		2/6 (33.3%)
Dehydration	4/17 (23.5%)		0/6 (0%)
Hyperglycaemia	5/17 (29.4%)		0/6 (0%)
Hyperkalaemia	0/17 (0%)		1/6 (16.7%)
Hypermagnesaemia	0/17 (0%)		1/6 (16.7%)
Hypernatraemia	0/17 (0%)		1/6 (16.7%)
Hypocalcaemia	0/17 (0%)		1/6 (16.7%)
Hyponatraemia	1/17 (5.9%)		0/6 (0%)
Musculoskeletal and connective tissue disorders
Back pain	2/17 (11.8%)		3/6 (50%)
Bone pain	1/17 (5.9%)		0/6 (0%)
Bone swelling	1/17 (5.9%)		0/6 (0%)
Flank pain	1/17 (5.9%)		0/6 (0%)
Joint swelling	0/17 (0%)		1/6 (16.7%)
Muscle spasms	5/17 (29.4%)		3/6 (50%)
Muscular weakness	1/17 (5.9%)		0/6 (0%)
Musculoskeletal chest pain	2/17 (11.8%)		1/6 (16.7%)
Musculoskeletal pain	1/17 (5.9%)		0/6 (0%)
Myalgia	1/17 (5.9%)		0/6 (0%)
Pain in extremity	2/17 (11.8%)		1/6 (16.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal neoplasm	1/17 (5.9%)		0/6 (0%)
Nervous system disorders
Convulsion	1/17 (5.9%)		0/6 (0%)
Dizziness	2/17 (11.8%)		0/6 (0%)
Dysgeusia	3/17 (17.6%)		0/6 (0%)
Dyskinesia	1/17 (5.9%)		0/6 (0%)
Facial nerve disorder	1/17 (5.9%)		0/6 (0%)
Headache	2/17 (11.8%)		2/6 (33.3%)
Hemiparesis	0/17 (0%)		1/6 (16.7%)
Intracranial pressure increased	0/17 (0%)		1/6 (16.7%)
Paraesthesia	2/17 (11.8%)		0/6 (0%)
Paraesthesia mucosal	1/17 (5.9%)		0/6 (0%)
Sensory disturbance	0/17 (0%)		1/6 (16.7%)
Somnolence	1/17 (5.9%)		1/6 (16.7%)
Spinal cord compression	1/17 (5.9%)		0/6 (0%)
Psychiatric disorders
Anxiety	1/17 (5.9%)		0/6 (0%)
Confusional state	1/17 (5.9%)		0/6 (0%)
Depression	1/17 (5.9%)		0/6 (0%)
Insomnia	1/17 (5.9%)		0/6 (0%)
Renal and urinary disorders
Pollakiuria	1/17 (5.9%)		1/6 (16.7%)
Urinary retention	1/17 (5.9%)		0/6 (0%)
Reproductive system and breast disorders
Atrophic vulvovaginitis	0/17 (0%)		1/6 (16.7%)
Vaginal ulceration	1/17 (5.9%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	4/17 (23.5%)		1/6 (16.7%)
Dysphonia	1/17 (5.9%)		1/6 (16.7%)
Dyspnoea	3/17 (17.6%)		1/6 (16.7%)
Dyspnoea exertional	0/17 (0%)		1/6 (16.7%)
Hiccups	2/17 (11.8%)		0/6 (0%)
Oropharyngeal pain	1/17 (5.9%)		0/6 (0%)
Pleural effusion	1/17 (5.9%)		0/6 (0%)
Pulmonary congestion	1/17 (5.9%)		0/6 (0%)
Pulmonary embolism	1/17 (5.9%)		0/6 (0%)
Wheezing	1/17 (5.9%)		0/6 (0%)
Skin and subcutaneous tissue disorders
Alopecia	2/17 (11.8%)		0/6 (0%)
Dermatitis	0/17 (0%)		1/6 (16.7%)
Dry skin	0/17 (0%)		1/6 (16.7%)
Ecchymosis	1/17 (5.9%)		0/6 (0%)
Nail disorder	1/17 (5.9%)		0/6 (0%)
Palmar-plantar erythrodysaesthesia syndrome	0/17 (0%)		1/6 (16.7%)
Pruritus	1/17 (5.9%)		1/6 (16.7%)
Pruritus generalised	1/17 (5.9%)		0/6 (0%)
Psoriasis	0/17 (0%)		1/6 (16.7%)
Skin disorder	0/17 (0%)		1/6 (16.7%)
Urticaria	1/17 (5.9%)		0/6 (0%)
Vascular disorders
Deep vein thrombosis	1/17 (5.9%)		0/6 (0%)
Haematoma	0/17 (0%)		1/6 (16.7%)
Pelvic venous thrombosis	0/17 (0%)		1/6 (16.7%)

Limitations/Caveats

The study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

More Information

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.