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Trial record 2 of 6 for:    "Peritoneal Mesothelioma" | "Antibodies"

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

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ClinicalTrials.gov Identifier: NCT01160458
Recruitment Status : Completed
First Posted : July 12, 2010
Results First Posted : May 14, 2013
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Raffit Hassan, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pleural Mesothelioma
Peritoneal Mesothelioma
Intervention Drug: IMC-A12
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description 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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  50.0%
>=65 years
10
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
63.28  (13.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
1
   5.0%
Not Hispanic or Latino
19
  95.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   5.0%
Black or African American
1
   5.0%
White
18
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Clinical Response Rate (PR+CR)
Hide Description 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.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
0
   0.0%
2.Secondary Outcome
Title Safety of IMC-A12 in Patients With Mesothelioma
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame Date treatment consent signed to date off study, approximately 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
 100.0%
3.Secondary Outcome
Title Duration of Overall Response
Hide Description 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).
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants had a complete response or partial response.
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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).
Time Frame To study completion, an average of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew from the study and was excluded from the analysis.
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: months
1.8
(1.4 to 5.5)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is the time interval from the start of treatment to the date of death.
Time Frame To study completion, an average of 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
One participant withdrew from the study and was excluded from the analysis.
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 19
Median (95% Confidence Interval)
Unit of Measure: Months
5.5
(2.1 to 12.2)
Time Frame Date treatment consent signed to date off study, approximately 36 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IMC-A12 Monotherapy in Patients
Hide Arm/Group Description 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)
All-Cause Mortality
IMC-A12 Monotherapy in Patients
Affected / at Risk (%)
Total   16/20 (80.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
IMC-A12 Monotherapy in Patients
Affected / at Risk (%) # Events
Total   19/20 (95.00%)    
Blood and lymphatic system disorders   
Anemia  1  4/20 (20.00%)  4
Cardiac disorders   
Atrial flutter  1  1/20 (5.00%)  1
Gastrointestinal disorders   
Abdominal distention  1  1/20 (5.00%)  1
Abdominal pain  1  4/20 (20.00%)  4
Dental caries  1  1/20 (5.00%)  1
Dyspepsia  1  2/20 (10.00%)  2
Mucositis Oral  1  1/20 (5.00%)  1
Nausea  1  2/20 (10.00%)  2
Small intestinal obstruction  1  1/20 (5.00%)  1
Vomiting  1  1/20 (5.00%)  1
General disorders   
Death NOS  1  16/20 (80.00%)  16
Fatigue  1  10/20 (50.00%)  11
Infusion related reaction  1  1/20 (5.00%)  1
Immune system disorders   
Allergic rhinitis  1  1/20 (5.00%)  1
Infections and infestations   
Infections and infestations - Other, thrush  1  1/20 (5.00%)  1
Sinusitis  1  2/20 (10.00%)  2
Investigations   
Alkaline phosphatase increased  1  2/20 (10.00%)  3
Creatinine increased  1  2/20 (10.00%)  4
Lymphocyte count decreased  1  2/20 (10.00%)  3
Weight loss  1  4/20 (20.00%)  4
Metabolism and nutrition disorders   
Anorexia  1  7/20 (35.00%)  7
Dehydration  1  7/20 (35.00%)  7
Hypercalcemia  1  1/20 (5.00%)  1
Hyperglycemia  1  2/20 (10.00%)  4
Hyperkalemia  1  4/20 (20.00%)  6
Hypoalbuminemia  1  5/20 (25.00%)  5
Hypocalcemia  1  2/20 (10.00%)  2
Hyponatremia  1  1/20 (5.00%)  1
Hypophosphatemia  1  2/20 (10.00%)  3
Musculoskeletal and connective tissue disorders   
Back pain  1  3/20 (15.00%)  3
Chest wall pain  1  1/20 (5.00%)  2
Muscle weakness lower limb  1  1/20 (5.00%)  1
Neck pain  1  1/20 (5.00%)  1
Pain in extremity  1  1/20 (5.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, mailgnant and unspecified (incl cysts and polyps)-Other, specify  1  9/20 (45.00%)  9
Nervous system disorders   
Dysphasia  1  1/20 (5.00%)  1
Psychiatric disorders   
Confusion  1  1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/20 (10.00%)  2
Vascular disorders   
Hypotension  1  3/20 (15.00%)  4
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IMC-A12 Monotherapy in Patients
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  3/20 (15.00%)  4
Cardiac disorders   
Sinus tachycardia  1  1/20 (5.00%)  1
Eye disorders   
Blurred vision  1  1/20 (5.00%)  1
Floaters  1  4/20 (20.00%)  5
Watering eyes  1  1/20 (5.00%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/20 (5.00%)  1
Bloating  1  1/20 (5.00%)  1
Constipation  1  2/20 (10.00%)  2
Diarrhea  1  3/20 (15.00%)  3
Dry mouth  1  2/20 (10.00%)  2
Dyspepsia  1  3/20 (15.00%)  3
Nausea  1  4/20 (20.00%)  4
Oral pain  1  1/20 (5.00%)  2
Sore throat  1  1/20 (5.00%)  1
Vomiting  1  5/20 (25.00%)  6
General disorders   
Chills  1  1/20 (5.00%)  1
Fatigue  1  8/20 (40.00%)  8
Fever  1  2/20 (10.00%)  2
Injury, poisoning and procedural complications   
Bruising  1  1/20 (5.00%)  1
Fall  1  2/20 (10.00%)  2
Investigations   
Alanine aminotransferase increased  1  2/20 (10.00%)  2
Alkaline phosphatase increased  1  4/20 (20.00%)  6
Aspartate aminotransferase increased  1  2/20 (10.00%)  6
Creatinine increased  1  5/20 (25.00%)  20
Lipase increased  1  1/20 (5.00%)  1
Lymphocyte count decreased  1  3/20 (15.00%)  9
Platelet count decreased  1  6/20 (30.00%)  12
Weight loss  1  12/20 (60.00%)  14
Metabolism and nutrition disorders   
Anorexia  1  4/20 (20.00%)  4
Hyperglycemia  1  14/20 (70.00%)  30
Hyperkalemia  1  7/20 (35.00%)  7
Hypermagnesemia  1  1/20 (5.00%)  1
Hyperuricemia  1  1/20 (5.00%)  1
Hypoalbuminemia  1  1/20 (5.00%)  6
Hypocalcemia  1  1/20 (5.00%)  1
Hypoglycemia  1  1/20 (5.00%)  1
Hypomagnesemia  1  5/20 (25.00%)  9
Hyponatremia  1  8/20 (40.00%)  13
Hypophosphatemia  1  1/20 (5.00%)  1
Nervous system disorders   
Dysgeusia  1  2/20 (10.00%)  2
Headache  1  2/20 (10.00%)  2
Transient ischemic attacks  1  1/20 (5.00%)  1
Dizziness  1  5/20 (25.00%)  5
Dysphasia  1  1/20 (5.00%)  1
Psychiatric disorders   
Insomnia  1  3/20 (15.00%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/20 (10.00%)  2
Epistaxis  1  1/20 (5.00%)  1
Nasal congestion  1  2/20 (10.00%)  2
Skin and subcutaneous tissue disorders   
Alopecia  1  1/20 (5.00%)  1
Dry skin  1  1/20 (5.00%)  1
Pruritus  1  1/20 (5.00%)  3
Vascular disorders   
Hypotension  1  1/20 (5.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Raffit Hassan, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-451-8742
EMail: hassanr@mail.nih.gov
Layout table for additonal information
Responsible Party: Raffit Hassan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01160458     History of Changes
Other Study ID Numbers: 100146
10-C-0146
First Submitted: July 9, 2010
First Posted: July 12, 2010
Results First Submitted: March 20, 2013
Results First Posted: May 14, 2013
Last Update Posted: April 10, 2018