Status:
COMPLETED
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
Lead Sponsor:
Morphotek
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.
Eligibility Criteria
Inclusion
- Primary
- 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
- 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.
Key Trial Info
Start Date :
December 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2014
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00738582
Start Date
December 31 2008
End Date
January 10 2014
Last Update
September 22 2022
Active Locations (28)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
2
University of California, San Diego
La Jolla, California, United States, 92093
3
UCLA Medical Hematology & Oncology
Los Angeles, California, United States, 90095
4
University of California, San Francisco
San Francisco, California, United States, 94115