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.
|First Received Date||August 19, 2008|
|Last Changed Date||November 13, 2015|
|Start Date||December 2008|
|Actual Primary Completion Date||June 2011|
|Primary Outcome Measures||
Progression free survival using the EORTC modified RECIST criteria. [Time Frame: 1 year]
|Secondary Outcome Measures||
Overall response, duration of survival, overall survival and safety. [Time Frame: 1 year]
|Study Arms / Comparison Groups||1 / 0|
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
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.
|Verification Date||November 2015|