Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00976508
First received: September 10, 2009
Last updated: October 23, 2013
Last verified: October 2013
Results First Received: October 23, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colorectal Neoplasms
Lung Neoplasms
Breast Neoplasms
Prostatic Neoplasms
Sarcoma
Interventions: Drug: figitumumab
Drug: pegvisomant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Figitumumab 20mg/kg + Pegvisomant 10 mg 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 20mg/kg + Pegvisomant 20 mg 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.

Participant Flow:   Overall Study
    Figitumumab 20mg/kg + Pegvisomant 10 mg     Figitumumab 20mg/kg + Pegvisomant 20 mg  
STARTED     17 [1]   6  
COMPLETED     3 [2]   0  
NOT COMPLETED     14     6  
Death                 7                 1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 1                 0  
Disease Progression                 4                 4  
Subject Enrolled in Hospice                 1                 0  
Terminated by the Sponsor                 0                 1  
[1] 18 subjects were enrolled; 17 subjects were treated; 1 subject was not eligible.
[2] These subjects withdrew from last study treatment due to progressive disease.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Figitumumab 20 mg/kg +Pegvisomant 10 mg 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 mg/kg + Pegvisomant 20 mg 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 Total of all reporting groups

Baseline Measures
    Figitumumab 20 mg/kg +Pegvisomant 10 mg     Figitumumab 20 mg/kg + Pegvisomant 20 mg     Total  
Number of Participants  
[units: participants]
  17     6     23  
Age  
[units: Years]
Mean ± Standard Deviation
  49.5  ± 17.4     32.3  ± 9.8     45.0  ± 17.4  
Gender  
[units: Participants]
     
Female     8     5     13  
Male     9     1     10  



  Outcome Measures
  Show All Outcome Measures

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

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

3.  Secondary:   Serum Circulating Insulin-like Growth Factor (IGF-1) Levels   [ 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) ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   Plasma Concentration at the Last Quantifiable Time Point (Clast) 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 ]

8.  Secondary:   Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab   [ 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) ]

9.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)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 ]

10.  Secondary:   Area Under the Trough Concentrations (AUCtrough)   [ 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 ]

11.  Secondary:   Mean Change in Glucose Levels Between Fasting and Post Glucose Load   [ Time Frame: Screening; Day 8 of Cycle 1; Day 15 of Cycle 2 ]

12.  Secondary:   Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response 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) ]

13.  Secondary:   Number of Participants With Objective 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) ]


  Serious Adverse Events
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Time Frame No text entered.
Additional 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.

Reporting Groups
  Description
Figitumumab 20 mg/kg + Pegvisomant 10 mg 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 mg/kg + Pegvisomant 20 mg 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.

Serious Adverse Events
    Figitumumab 20 mg/kg + Pegvisomant 10 mg     Figitumumab 20 mg/kg + Pegvisomant 20 mg  
Total, serious adverse events      
# participants affected / at risk     9/17 (52.94%)     4/6 (66.67%)  
Gastrointestinal disorders      
Gastrointestinal haemorrhage * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
General disorders      
Death * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Disease progression * 1    
# participants affected / at risk     4/17 (23.53%)     1/6 (16.67%)  
Fatigue * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
General physical health deterioration * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Medical device complication * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Pain * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Pyrexia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Infections and infestations      
Pelvic infection * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Investigations      
Blood uric acid increased * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
C-reactive protein increased * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Metabolism and nutrition disorders      
Dehydration * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Musculoskeletal and connective tissue disorders      
Back pain * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Flank pain * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Nervous system disorders      
Cauda equina syndrome * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Headache * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Pneumonitis * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA v14.1




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.


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