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


  Other 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.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Figitumumab 20 mg/kg + Pegvisomant 10 mg     Figitumumab 20 mg/kg + Pegvisomant 20 mg  
Total, other (not including serious) adverse events      
# participants affected / at risk     17/17     6/6  
Blood and lymphatic system disorders      
Anaemia * 1    
# participants affected / at risk     1/17 (5.88%)     2/6 (33.33%)  
Lymphadenopathy * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Neutropenia * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Thrombocytopenia * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Cardiac disorders      
Tachycardia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Ear and labyrinth disorders      
Ear discomfort * 1    
# participants affected / at risk     1/17 (5.88%)     2/6 (33.33%)  
Hearing impaired * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Sudden hearing loss * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Eye disorders      
Dry eye * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Ocular hyperaemia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Gastrointestinal disorders      
Abdominal discomfort * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Abdominal distension * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Abdominal pain * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Abdominal pain lower * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Abdominal pain upper * 1    
# participants affected / at risk     0/17 (0.00%)     2/6 (33.33%)  
Constipation * 1    
# participants affected / at risk     5/17 (29.41%)     2/6 (33.33%)  
Diarrhoea * 1    
# participants affected / at risk     7/17 (41.18%)     4/6 (66.67%)  
Dry mouth * 1    
# participants affected / at risk     3/17 (17.65%)     0/6 (0.00%)  
Dyspepsia * 1    
# participants affected / at risk     2/17 (11.76%)     3/6 (50.00%)  
Dysphagia * 1    
# participants affected / at risk     0/17 (0.00%)     2/6 (33.33%)  
Erosive oesophagitis * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Eructation * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Flatulence * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Gastric ulcer * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Gastritis * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Gastrooesophageal reflux disease * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Hiatus hernia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Impaired gastric emptying * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Nausea * 1    
# participants affected / at risk     9/17 (52.94%)     2/6 (33.33%)  
Proctalgia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Rectal haemorrhage * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Stomatitis * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Vomiting * 1    
# participants affected / at risk     4/17 (23.53%)     1/6 (16.67%)  
General disorders      
Asthenia * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Chest pain * 1    
# participants affected / at risk     2/17 (11.76%)     2/6 (33.33%)  
Chills * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Disease progression * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Exercise tolerance decreased * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Fatigue * 1    
# participants affected / at risk     13/17 (76.47%)     4/6 (66.67%)  
General physical health deterioration * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Injection site induration * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Injection site reaction * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Medical device pain * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Mucosal inflammation * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Necrosis * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Oedema peripheral * 1    
# participants affected / at risk     2/17 (11.76%)     1/6 (16.67%)  
Pain * 1    
# participants affected / at risk     2/17 (11.76%)     1/6 (16.67%)  
Pyrexia * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Thirst * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Hepatobiliary disorders      
Cholangitis * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Immune system disorders      
Contrast media allergy * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Infections and infestations      
Fungal infection * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Lung infection * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Nasopharyngitis * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Paronychia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Pelvic infection * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Rhinitis * 1    
# participants affected / at risk     0/17 (0.00%)     2/6 (33.33%)  
Sinusitis * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Upper respiratory tract infection * 1    
# participants affected / at risk     2/17 (11.76%)     1/6 (16.67%)  
Urinary tract infection * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Wound infection * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Injury, poisoning and procedural complications      
Contusion * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Fall * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Procedural pain * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Thermal burn * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Investigations      
Alanine aminotransferase increased * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Aspartate aminotransferase increased * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Blood albumin decreased * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Blood alkaline phosphatase increased * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Blood bilirubin increased * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Blood creatinine increased * 1    
# participants affected / at risk     3/17 (17.65%)     2/6 (33.33%)  
Blood uric acid increased * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
C-reactive protein increased * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Gamma-glutamyltransferase increased * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Haemoglobin decreased * 1    
# participants affected / at risk     3/17 (17.65%)     1/6 (16.67%)  
Insulin-like growth factor increased * 1    
# participants affected / at risk     0/17 (0.00%)     2/6 (33.33%)  
International normalised ratio increased * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Neutrophil count decreased * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Platelet count decreased * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Weight decreased * 1    
# participants affected / at risk     3/17 (17.65%)     3/6 (50.00%)  
Weight increased * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Metabolism and nutrition disorders      
Decreased appetite * 1    
# participants affected / at risk     9/17 (52.94%)     2/6 (33.33%)  
Dehydration * 1    
# participants affected / at risk     4/17 (23.53%)     0/6 (0.00%)  
Hyperglycaemia * 1    
# participants affected / at risk     5/17 (29.41%)     0/6 (0.00%)  
Hyperkalaemia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Hypermagnesaemia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Hypernatraemia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Hypocalcaemia * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Hyponatraemia * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Musculoskeletal and connective tissue disorders      
Back pain * 1    
# participants affected / at risk     2/17 (11.76%)     3/6 (50.00%)  
Bone pain * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Bone swelling * 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%)  
Joint swelling * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Muscle spasms * 1    
# participants affected / at risk     5/17 (29.41%)     3/6 (50.00%)  
Muscular weakness * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Musculoskeletal chest pain * 1    
# participants affected / at risk     2/17 (11.76%)     1/6 (16.67%)  
Musculoskeletal pain * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Myalgia * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Pain in extremity * 1    
# participants affected / at risk     2/17 (11.76%)     1/6 (16.67%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Vaginal neoplasm * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Nervous system disorders      
Convulsion * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Dizziness * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Dysgeusia * 1    
# participants affected / at risk     3/17 (17.65%)     0/6 (0.00%)  
Dyskinesia * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Facial nerve disorder * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Headache * 1    
# participants affected / at risk     2/17 (11.76%)     2/6 (33.33%)  
Hemiparesis * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Intracranial pressure increased * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Paraesthesia * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Paraesthesia mucosal * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Sensory disturbance * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Somnolence * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Spinal cord compression * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Psychiatric disorders      
Anxiety * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Confusional state * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Depression * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Insomnia * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Renal and urinary disorders      
Pollakiuria * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Urinary retention * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Reproductive system and breast disorders      
Atrophic vulvovaginitis * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Vaginal ulceration * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Cough * 1    
# participants affected / at risk     4/17 (23.53%)     1/6 (16.67%)  
Dysphonia * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Dyspnoea * 1    
# participants affected / at risk     3/17 (17.65%)     1/6 (16.67%)  
Dyspnoea exertional * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Hiccups * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Oropharyngeal pain * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Pleural effusion * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Pulmonary congestion * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Pulmonary embolism * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Wheezing * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Skin and subcutaneous tissue disorders      
Alopecia * 1    
# participants affected / at risk     2/17 (11.76%)     0/6 (0.00%)  
Dermatitis * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Dry skin * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Ecchymosis * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Nail disorder * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Palmar-plantar erythrodysaesthesia syndrome * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Pruritus * 1    
# participants affected / at risk     1/17 (5.88%)     1/6 (16.67%)  
Pruritus generalised * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Psoriasis * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Skin disorder * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Urticaria * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Vascular disorders      
Deep vein thrombosis * 1    
# participants affected / at risk     1/17 (5.88%)     0/6 (0.00%)  
Haematoma * 1    
# participants affected / at risk     0/17 (0.00%)     1/6 (16.67%)  
Pelvic venous thrombosis * 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



  Limitations and Caveats
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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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00976508     History of Changes
Other Study ID Numbers: A4021040
Study First Received: September 10, 2009
Results First Received: October 23, 2013
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration