NCT02357147

Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Morphotek · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in combination with pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma (MPM) who have not received prior systemic therapy. Per a business decision made by the Sponsor, participants who were randomized to amatuximab and were still on active treatment at the time of the protocol amendment may have consented to continue to receive weekly treatment with amatuximab until disease progression or intolerable toxicity at the discretion of the principal investigator. Participants randomized to placebo or who were in follow-up at the time of the amendment have been discontinued from the study.

Conditions

• Mesothelioma, Malignant

Interventions

Type	Name	Description
DRUG	Placebo	Combination Phase - Placebo will be administered IV (intravenous infusion) once weekly for six 21-day cycles. Maintenance Phase - Placebo will be administered IV (intravenous infusion) once weekly until disease progression.
DRUG	Amatuximab	Combination Phase - Amatuximab 5mg/kg will be administered IV (intravenous infusion) once weekly for six 21-day cycles. Maintenance Phase - Amatuximab 5mg/kg will be administered IV (intravenous infusion) once weekly until disease progression.
DRUG	Pemetrexed	Combination Phase - Pemetrexed 500 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle for 6 cycles.
DRUG	Cisplatin	Combination Phase - Cisplatin 75 mg/m\^2 will be administered IV on Day 1 of each 21-day cycle for 6 cycles.

Timeline

• Start date: 2015-11-03
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2015-02-06
• Last updated: 2020-03-17
• Results posted: 2020-03-17

Locations

49 sites across 6 countries: United States, Australia, France, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated drug study