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NCT02357147 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)
A Phase 2 study, sponsored by Morphotek.
- Terminated
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT02357147 is a Phase 2 study that was terminated before completion, run by Morphotek. The registered enrollment target is 124 participants.
The verdict
NCT02357147, a Phase 2 study, was terminated before completion, sponsored by Morphotek.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Amatuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2015-11-03 |
| Est. Completion | 2018-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02357147
The ClinicalTrials.gov registry entry for NCT02357147 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Morphotek, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02357147 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02357147 about?
NCT02357147 is a clinical study titled "Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)". 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 i...
What is the current status of trial NCT02357147?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2015-11-03. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT02357147?
The interventions under investigation include: Placebo (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Amatuximab (DRUG).
Who is sponsoring clinical trial NCT02357147?
This trial is sponsored by Morphotek, which has 20 total clinical trials registered on ClinicalTrials.gov.
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