Trial Outcomes & Findings for IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery (NCT NCT00778817)

Last Updated: 2014-04-29

Results Overview

Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

6 weeks

Results posted on

2014-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy and Monoclonal Antibody Therapy Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy and Monoclonal Antibody Therapy Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy and Monoclonal Antibody Therapy n=20 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Age, Continuous	49.2 years STANDARD_DEVIATION 16.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: The analysis population excludes two patients who withdrew from the study before the 6 week assessment.

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=18 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Progression-free Survival Rate at 6 Weeks	50 percentage of participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The analysis population excludes two patients who withdrew from the study before the 6 week assessment.

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=18 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Progression-free Survival Rate at 12 Weeks	25 percentage of participants

PRIMARY outcome

Timeframe: 18 weeks

Population: The analysis population excludes two patients who withdrew from the study before the 6 week assessment.

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=18 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Progression-free Survival Rate at 18 Weeks	16.7 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 months

RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome.

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=20 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Best Response Rates Progressive disease (PD)	45 percentage of participants
Best Response Rates Stable disease (SD)	40 percentage of participants
Best Response Rates Partial response (PR)	5 percentage of participants
Best Response Rates Complete response (CR)	0 percentage of participants
Best Response Rates Unknown response	10 percentage of participants

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=20 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Response at 6 Weeks Progressive disease (PD)	45 percentage of participants
Response at 6 Weeks Stable disease (SD)	45 percentage of participants
Response at 6 Weeks Partial response (PR)	0 percentage of participants
Response at 6 Weeks Complete response (CR)	0 percentage of participants
Response at 6 Weeks Unknown response	10 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=20 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Response at 12 Weeks Progressive disease (PD)	60 percentage of participants
Response at 12 Weeks Stable disease (SD)	30 percentage of participants
Response at 12 Weeks Partial response (PR)	0 percentage of participants
Response at 12 Weeks Complete response (CR)	0 percentage of participants
Response at 12 Weeks Unknown response	10 percentage of participants

SECONDARY outcome

Timeframe: 18 weeks

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=20 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Response at 18 Weeks Progressive disease (PD)	65 percentage of participants
Response at 18 Weeks Stable disease (SD)	20 percentage of participants
Response at 18 Weeks Partial response (PR)	5 percentage of participants
Response at 18 Weeks Complete response (CR)	0 percentage of participants
Response at 18 Weeks Unknown response	10 percentage of participants

SECONDARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=20 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Response at 48 Weeks Progressive disease (PD)	65 percentage of participants
Response at 48 Weeks Stable disease (SD)	20 percentage of participants
Response at 48 Weeks Partial response (PR)	5 percentage of participants
Response at 48 Weeks Complete response (CR)	0 percentage of participants
Response at 48 Weeks Unknown response	10 percentage of participants

SECONDARY outcome

Timeframe: 6 weeks

Population: The analysis population excludes two patients who withdrew from the study before the 6 week assessment.

Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount).

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=18 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks	3 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: The analysis population excludes two patients who withdrew from the study before the 6 week assessment.

Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount).

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=18 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks	3 participants

SECONDARY outcome

Timeframe: 18 weeks

Population: The analysis population excludes two patients who withdrew from the study before the 6 week assessment.

Total number of patients whose tumor size at 18 weeks was smaller than their tumor size recorded at baseline (by any amount).

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=18 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Number of Patients Exhibiting Decrease in Tumor Size at 18 Weeks	2 participants

SECONDARY outcome

Timeframe: 48 weeks

Population: The analysis population excludes two patients who withdrew from the study before the 6 week assessment.

Total number of patients whose tumor size at 48 weeks was smaller than their tumor size recorded at baseline (by any amount).

Outcome measures

Outcome measures
Measure	Chemotherapy and Monoclonal Antibody Therapy n=18 Participants Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Number of Patients Exhibiting Decrease in Tumor Size at 48 Weeks	1 participants

Adverse Events

Chemotherapy and Monoclonal Antibody Therapy

Serious events: 9 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy and Monoclonal Antibody Therapy n=20 participants at risk Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • 6 months
Investigations Alanine aminotransferase increased	5.0% 1/20 • 6 months
Metabolism and nutrition disorders Anorexia	5.0% 1/20 • 6 months
Investigations Cholesterol high	5.0% 1/20 • 6 months
Nervous system disorders Cognitive disturbance	5.0% 1/20 • 6 months
Psychiatric disorders Confusion	5.0% 1/20 • 6 months
Investigations Creatinine increased	5.0% 1/20 • 6 months
Metabolism and nutrition disorders Dehydration	10.0% 2/20 • 6 months
Nervous system disorders Depressed level of consciousness	5.0% 1/20 • 6 months
Gastrointestinal disorders Diarrhea	5.0% 1/20 • 6 months
Nervous system disorders Dizziness	5.0% 1/20 • 6 months
General disorders Fatigue	5.0% 1/20 • 6 months
General disorders Fever	5.0% 1/20 • 6 months
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.0% 1/20 • 6 months
Metabolism and nutrition disorders Hyperglycemia	5.0% 1/20 • 6 months
Metabolism and nutrition disorders Hypertriglyceridemia	5.0% 1/20 • 6 months
Metabolism and nutrition disorders Hypoglycemia	5.0% 1/20 • 6 months
General disorders Multi-organ failure	5.0% 1/20 • 6 months
Gastrointestinal disorders Nausea	20.0% 4/20 • 6 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.0% 1/20 • 6 months
Nervous system disorders Tremor	5.0% 1/20 • 6 months
Gastrointestinal disorders Vomiting	15.0% 3/20 • 6 months

Other adverse events

Other adverse events
Measure	Chemotherapy and Monoclonal Antibody Therapy n=20 participants at risk Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Dehydration	5.0% 1/20 • 6 months
General disorders Fatigue	5.0% 1/20 • 6 months
Metabolism and nutrition disorders Hyperglycemia	10.0% 2/20 • 6 months

Additional Information

Walter M. Stadler, MD

The University of Chicago

Phone: (773) 702-6149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60