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IMC-A12 in Treating Patients With Advanced Liver Cancer

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ClinicalTrials.gov Identifier: NCT00639509
Recruitment Status : Completed
First Posted : March 20, 2008
Results First Posted : December 3, 2013
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Interventions Biological: cixutumumab
Procedure: computed tomography
Procedure: contrast-enhanced magnetic resonance imaging
Enrollment 24
Recruitment Details Protocol Open to Accrual 03/06/2008 Primary Completion Date 02/08/2011 Recruitment Location is medical clinic
Pre-assignment Details  
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 24
Completed 23
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title IMC-A12
Hide Arm/Group Description Participants will receive IMC-A12 at a dose of 6mg/kg IV over 1 hour on Day 1 every week.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  41.7%
>=65 years
14
  58.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
67.5  (9.469631093)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
4
  16.7%
Male
20
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title PFS Rate
Hide Description PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon’s optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.
Time Frame At 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:
Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30
(13 to 48)
2.Primary Outcome
Title Best Overall Response Rate (ORR)
Hide Description Best overall ORR will be defined as the proportion of patients achieving either confirmed partial response (PR) or confirmed complete response (CR). A Simon’s optimal two stage design will be used with the following assumption: ORR of more than 20% is acceptable and an ORR less than 5% is not acceptable.
Time Frame From the start of the treatment until disease progression/recurrence
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:
Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Median Overall Survival
Hide Description Median Overall Survival
Time Frame Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:
Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: months
8
(5.8 to 14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Monoclonal Antibody Therapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Monoclonal Antibody Therapy)
Affected / at Risk (%) # Events
Total   11/24 (45.83%)    
Gastrointestinal disorders   
Ascites  1/24 (4.17%)  1
Death not assoc w CTCAE term-Disease Progression  4/24 (16.67%)  4
Hemorrhage, Rectum  1/24 (4.17%)  1
Hemorrhage, Varices (esophageal)  1/24 (4.17%)  1
Vomiting  1/24 (4.17%)  1
Hepatobiliary disorders   
Bilirubin (hyperbilirubinemia)  1/24 (4.17%)  1
Investigations   
ALT, SGPT  3/24 (12.50%)  3
AST, SGOT  4/24 (16.67%)  4
Alkaline Phosphatase  1/24 (4.17%)  1
Platelets  1/24 (4.17%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1/24 (4.17%)  1
Dehydration  1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders   
Pain, Back  1/24 (4.17%)  1
Psychiatric disorders   
Confusion  1/24 (4.17%)  1
Renal and urinary disorders   
Renal failure  1/24 (4.17%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion (non-malig)  1/24 (4.17%)  1
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Monoclonal Antibody Therapy)
Affected / at Risk (%) # Events
Total   24/24 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  17/24 (70.83%)  17
Hemorrhage  3/24 (12.50%)  3
INR  15/24 (62.50%)  15
Eye disorders   
Vision blurred  2/24 (8.33%)  2
Gastrointestinal disorders   
Constipation  10/24 (41.67%)  10
Diarrhea  8/24 (33.33%)  8
Nausea  5/24 (20.83%)  5
Pain-Abdomen NOS  3/24 (12.50%)  3
Vomiting  3/24 (12.50%)  3
General disorders   
Fatigue  21/24 (87.50%)  21
Investigations   
ALT, SGPT  21/24 (87.50%)  21
AST, SGOT  23/24 (95.83%)  23
Alkaline phosphatase  17/24 (70.83%)  17
Hyperbilirubinemia  21/24 (87.50%)  21
Hypercholesterolemia  3/24 (12.50%)  3
Creatinine  9/24 (37.50%)  9
Leukocyte count decrease  10/24 (41.67%)  10
Lymphocyte count decrease  3/24 (12.50%)  3
Neutrophil count decrease  3/24 (12.50%)  3
Activated partial thromboplastin prolonged time  3/24 (12.50%)  3
Platelet count decrease  19/24 (79.17%)  19
Metabolism and nutrition disorders   
Hypoalbuminemia  24/24 (100.00%)  24
Hyperglycemia  24/24 (100.00%)  24
Hypoglycemia  2/24 (8.33%)  2
Serum Magnesium decrease  2/24 (8.33%)  2
Hypophosphatemia  3/24 (12.50%)  3
Potassium, high (hyperkalemia)  5/24 (20.83%)  5
Sodium, low (hyponatremia)  21/24 (87.50%)  21
Nervous system disorders   
Neurological disorder  2/24 (8.33%)  2
Respiratory, thoracic and mediastinal disorders   
Cough  2/24 (8.33%)  2
Dyspnea  8/24 (33.33%)  8
Skin and subcutaneous tissue disorders   
Skin Disorder  3/24 (12.50%)  3
1
Term from vocabulary, CTCAE 3.0
2
Term from vocabulary, CTCAE (3.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ghassan K. Abou-Alfa, MD
Organization: Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4184
EMail: abou-alg@mskcc.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00639509     History of Changes
Other Study ID Numbers: NCI-2009-00283
NCI-2009-00283 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-08015
CDR0000589633
08-015 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
8124 ( Other Identifier: CTEP )
P30CA008748 ( U.S. NIH Grant/Contract )
N01CM62206 ( U.S. NIH Grant/Contract )
First Submitted: March 19, 2008
First Posted: March 20, 2008
Results First Submitted: September 25, 2013
Results First Posted: December 3, 2013
Last Update Posted: May 23, 2014