An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Malignant Pleural Mesothelioma
Both
Malignant Pleural Mesothelioma
Trial Information
An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
Primary
Inclusion Criteria:
- Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following
characteristics: unresectable disease (or otherwise not a candidate for curative
surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.
- Measurable disease at Screening by computed tomography (CT)(or magnetic resonance
imaging [MRI]).
- KPS of greater than or equal to 70% at Screening.
- Life expectancy of at least 3 months
Primary Exclusion Criteria:
- Sarcomatous type of mesothelioma
- Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom
control (ie, non-curative intent) is permitted.
- Confirmed presence of CNS tumor involvement.
- Evidence of other active malignancy requiring treatment.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival using the EORTC modified RECIST criteria.
Outcome Time Frame:
1 year
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
MORAb-009-003 Amatuximab
NCT ID:
NCT00738582
Start Date:
December 2008
Completion Date:
February 2014
Related Keywords:
- Malignant Pleural Mesothelioma
- Mesothelioma
Name | Location |
|---|---|
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Emory University School of Medicine | Atlanta, Georgia 30322 |
| University of California, San Francisco | San Francisco, California 94143 |
| University of Chicago Medical Center | Chicago, Illinois 60637 |
| Mary Babb Randolph Cancer Center | Morgantown, West Virginia 26506 |
| University of California, San Diego | La Jolla, California 92037-1709 |
| University of Alabama, Birmingham | Birmingham, Alabama 35233 |
| Columbia University Medical Center | New York, New York 10032 |
| UCLA Medical Hematology & Oncology | Los Angeles, California 90095 |
| Christiana Care Health System | Newark, Delaware 19713 |
| Johns Hopkins University--Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21201 |
| NIH/National Cancer Institute | Bethesda, Maryland 20892 |
