Trial Outcomes & Findings for IMC-A12 in Treating Patients With Advanced Liver Cancer (NCT NCT00639509)
NCT ID: NCT00639509
Last Updated: 2014-05-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
At 4 months
Results posted on
2014-05-23
Participant Flow
Protocol Open to Accrual 03/06/2008 Primary Completion Date 02/08/2011 Recruitment Location is medical clinic
Participant milestones
| Measure |
Treatment (Monoclonal Antibody Therapy)
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 Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Monoclonal Antibody Therapy)
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 Study
Death
|
1
|
Baseline Characteristics
IMC-A12 in Treating Patients With Advanced Liver Cancer
Baseline characteristics by cohort
| Measure |
IMC-A12
n=24 Participants
Participants will receive IMC-A12 at a dose of 6mg/kg IV over 1 hour on Day 1 every week.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.469631093 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4 monthsPFS 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.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody Therapy)
n=23 Participants
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.
|
|---|---|
|
PFS Rate
|
30 percentage of participants
Interval 13.0 to 48.0
|
PRIMARY outcome
Timeframe: From the start of the treatment until disease progression/recurrenceBest 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.
Outcome measures
| Measure |
Treatment (Monoclonal Antibody Therapy)
n=23 Participants
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.
|
|---|---|
|
Best Overall Response Rate (ORR)
|
0 participants
|
SECONDARY outcome
Timeframe: Post-TreatmentMedian Overall Survival
Outcome measures
| Measure |
Treatment (Monoclonal Antibody Therapy)
n=23 Participants
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.
|
|---|---|
|
Median Overall Survival
|
8 months
Interval 5.8 to 14.0
|
Adverse Events
Treatment (Monoclonal Antibody Therapy)
Serious events: 11 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Monoclonal Antibody Therapy)
n=24 participants at risk
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.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.2%
1/24 • Number of events 1
|
|
Investigations
ALT, SGPT
|
12.5%
3/24 • Number of events 3
|
|
Investigations
AST, SGOT
|
16.7%
4/24 • Number of events 4
|
|
Investigations
Alkaline Phosphatase
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
4.2%
1/24 • Number of events 1
|
|
Hepatobiliary disorders
Bilirubin (hyperbilirubinemia)
|
4.2%
1/24 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Death not assoc w CTCAE term-Disease Progression
|
16.7%
4/24 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, Rectum
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, Varices (esophageal)
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
4.2%
1/24 • Number of events 1
|
|
Investigations
Platelets
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malig)
|
4.2%
1/24 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Monoclonal Antibody Therapy)
n=24 participants at risk
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.
|
|---|---|
|
Investigations
ALT, SGPT
|
87.5%
21/24 • Number of events 21
|
|
Investigations
AST, SGOT
|
95.8%
23/24 • Number of events 23
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
24/24 • Number of events 24
|
|
Investigations
Alkaline phosphatase
|
70.8%
17/24 • Number of events 17
|
|
Investigations
Hyperbilirubinemia
|
87.5%
21/24 • Number of events 21
|
|
Investigations
Hypercholesterolemia
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
41.7%
10/24 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2
|
|
Investigations
Creatinine
|
37.5%
9/24 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
8/24 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
8/24 • Number of events 8
|
|
General disorders
Fatigue
|
87.5%
21/24 • Number of events 21
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
24/24 • Number of events 24
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
70.8%
17/24 • Number of events 17
|
|
Blood and lymphatic system disorders
Hemorrhage
|
12.5%
3/24 • Number of events 3
|
|
Blood and lymphatic system disorders
INR
|
62.5%
15/24 • Number of events 15
|
|
Investigations
Leukocyte count decrease
|
41.7%
10/24 • Number of events 10
|
|
Investigations
Lymphocyte count decrease
|
12.5%
3/24 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum Magnesium decrease
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
20.8%
5/24 • Number of events 5
|
|
Nervous system disorders
Neurological disorder
|
8.3%
2/24 • Number of events 2
|
|
Investigations
Neutrophil count decrease
|
12.5%
3/24 • Number of events 3
|
|
Investigations
Activated partial thromboplastin prolonged time
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
Pain-Abdomen NOS
|
12.5%
3/24 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
3/24 • Number of events 3
|
|
Investigations
Platelet count decrease
|
79.2%
19/24 • Number of events 19
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
20.8%
5/24 • Number of events 5
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
87.5%
21/24 • Number of events 21
|
|
Eye disorders
Vision blurred
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
3/24 • Number of events 3
|
Additional Information
Ghassan K. Abou-Alfa, MD
Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4184
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60