NCT00738582

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

An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Morphotek · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
DRUG	MORAb-009 (Amatuximab)	MORAb-009 (Amatuximab) by IV on Days 1 and 8 every 21 days for 6 cycles.
DRUG	Pemetrexed	Pemetrexed 500 mg/m2 on Day 1 of each 21-day cycle for 6 cycles
DRUG	Cisplatin	Cisplatin 75 mg/m2 on Day 1 of each 21-day cycle for 6 cycles

Timeline

• Start date: 2008-12-31
• Primary completion: 2011-06-30
• Completion: 2014-01-10
• First posted: 2008-08-20
• Last updated: 2022-09-22
• Results posted: 2022-09-22

Locations

28 sites across 5 countries: United States, Canada, Germany, Netherlands, Spain

Regulatory

• FDA-regulated drug study