Brief Title
An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma
Official Title
An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression free survival using the EORTC modified RECIST criteria.
Secondary Outcome
Overall response, duration of survival, overall survival and safety.
Condition
Malignant Pleural Mesothelioma
Intervention
MORAb-009 (Amatuximab)
Study Arms / Comparison Groups
Open Label
Description: Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
89
Start Date
December 2008
Completion Date
January 2014
Primary Completion Date
June 2011
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bruce Wallin, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00738582
Organization ID
MORAb-009-003 Amatuximab
Responsible Party
Sponsor
Study Sponsor
Morphotek
Study Sponsor
Bruce Wallin, MD, Study Director, Morphotek
Verification Date
November 2015