Trial Outcomes & Findings for Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy (NCT NCT01160458)

Last Updated: 2018-04-10

Results Overview

Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

36 months

Results posted on

2018-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	IMC-A12 Monotherapy in Patients 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMC-A12 Monotherapy in Patients n=20 Participants 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
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	10 Participants n=5 Participants
Age, Continuous	63.28 years STANDARD_DEVIATION 13.28 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Outcome measures

Outcome measures
Measure	IMC-A12 Monotherapy in Patients n=20 Participants 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
Clinical Response Rate (PR+CR) Complete Response	0 Participants
Clinical Response Rate (PR+CR) Partial Response	0 Participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 36 months

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

Outcome measures

Outcome measures
Measure	IMC-A12 Monotherapy in Patients n=20 Participants 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
Safety of IMC-A12 in Patients With Mesothelioma	20 Participants

SECONDARY outcome

Timeframe: 36 months

Population: No participants had a complete response or partial response.

Duration of Overall Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: To study completion, an average of 3 years

Population: One participant withdrew from the study and was excluded from the analysis.

Progression Free Survival is defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study longest diameter (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	IMC-A12 Monotherapy in Patients n=19 Participants 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
Progression Free Survival (PFS)	1.8 months Interval 1.4 to 5.5

SECONDARY outcome

Timeframe: To study completion, an average of 3 years

Population: One participant withdrew from the study and was excluded from the analysis.

Overall survival is the time interval from the start of treatment to the date of death.

Outcome measures

Outcome measures
Measure	IMC-A12 Monotherapy in Patients n=19 Participants 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
Overall Survival (OS)	5.5 Months Interval 2.1 to 12.2

Adverse Events

IMC-A12 Monotherapy in Patients

Serious events: 19 serious events

Other events: 20 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	IMC-A12 Monotherapy in Patients n=20 participants at risk 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Musculoskeletal and connective tissue disorders Neck pain	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, mailgnant and unspecified (incl cysts and polyps)-Other, specify	45.0% 9/20 • Number of events 9 • Date treatment consent signed to date off study, approximately 36 months.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Infections and infestations Sinusitis	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Abdominal distention	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Abdominal pain	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Alkaline phosphatase increased	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
Immune system disorders Allergic rhinitis	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Blood and lymphatic system disorders Anemia	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Anorexia	35.0% 7/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 36 months.
Cardiac disorders Atrial flutter	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Musculoskeletal and connective tissue disorders Back pain	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
Musculoskeletal and connective tissue disorders Chest wall pain	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Psychiatric disorders Confusion	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Creatinine increased	10.0% 2/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
General disorders Death NOS	80.0% 16/20 • Number of events 16 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Dehydration	35.0% 7/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Dental caries	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Dyspepsia	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Nervous system disorders Dysphasia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
General disorders Fatigue	50.0% 10/20 • Number of events 11 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypercalcemia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hyperglycemia	10.0% 2/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hyperkalemia	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 5/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypocalcemia	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hyponatremia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypophosphatemia	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
Vascular disorders Hypotension	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
Infections and infestations Infections and infestations - Other, thrush	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
General disorders Infusion related reaction	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Lymphocyte count decreased	10.0% 2/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Mucositis Oral	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Small intestinal obstruction	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Weight loss	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.

Other adverse events

Other adverse events
Measure	IMC-A12 Monotherapy in Patients n=20 participants at risk 20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Alanine aminotransferase increased	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Alkaline phosphatase increased	20.0% 4/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 36 months.
Skin and subcutaneous tissue disorders Alopecia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Blood and lymphatic system disorders Anemia	15.0% 3/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Anorexia	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Aspartate aminotransferase increased	10.0% 2/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Bloating	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Eye disorders Blurred vision	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Injury, poisoning and procedural complications Bruising	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
General disorders Chills	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Constipation	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Creatinine increased	25.0% 5/20 • Number of events 20 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Diarrhea	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Dry mouth	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Skin and subcutaneous tissue disorders Dry skin	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Nervous system disorders Dysgeusia	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Dyspepsia	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Injury, poisoning and procedural complications Fall	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
General disorders Fatigue	40.0% 8/20 • Number of events 8 • Date treatment consent signed to date off study, approximately 36 months.
General disorders Fever	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Eye disorders Floaters	20.0% 4/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 36 months.
Nervous system disorders Headache	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hyperglycemia	70.0% 14/20 • Number of events 30 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hyperkalemia	35.0% 7/20 • Number of events 7 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypermagnesemia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hyperuricemia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypoalbuminemia	5.0% 1/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypocalcemia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypoglycemia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 5/20 • Number of events 9 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hyponatremia	40.0% 8/20 • Number of events 13 • Date treatment consent signed to date off study, approximately 36 months.
Metabolism and nutrition disorders Hypophosphatemia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Vascular disorders Hypotension	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Psychiatric disorders Insomnia	15.0% 3/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Lipase increased	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Lymphocyte count decreased	15.0% 3/20 • Number of events 9 • Date treatment consent signed to date off study, approximately 36 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	10.0% 2/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Nausea	20.0% 4/20 • Number of events 4 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Oral pain	5.0% 1/20 • Number of events 2 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Platelet count decreased	30.0% 6/20 • Number of events 12 • Date treatment consent signed to date off study, approximately 36 months.
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Number of events 3 • Date treatment consent signed to date off study, approximately 36 months.
Cardiac disorders Sinus tachycardia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Sore throat	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Nervous system disorders Transient ischemic attacks	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Gastrointestinal disorders Vomiting	25.0% 5/20 • Number of events 6 • Date treatment consent signed to date off study, approximately 36 months.
Eye disorders Watering eyes	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.
Investigations Weight loss	60.0% 12/20 • Number of events 14 • Date treatment consent signed to date off study, approximately 36 months.
Nervous system disorders Dizziness	25.0% 5/20 • Number of events 5 • Date treatment consent signed to date off study, approximately 36 months.
Nervous system disorders Dysphasia	5.0% 1/20 • Number of events 1 • Date treatment consent signed to date off study, approximately 36 months.

Additional Information

Dr. Raffit Hassan, M.D.

National Cancer Institute, National Institutes of Health

Phone: 301-451-8742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place