An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Antibodies, Monoclonal; Cisplatin; Pemetrexed

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.