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NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)
The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
Details
| Lead sponsor | AGC Biologics S.p.A. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 400 |
| Start date | 2010-04-12 |
| Completion | 2017-12 |
Conditions
- Malignant Pleural Mesothelioma
Interventions
- NGR-hTNF plus Best Investigator's Choice (BIC)
- Placebo plus Best Investigator's Choice (BIC)
Primary outcomes
- Overall Survival (OS) — From date of randomization until the date of first documented progression or date of death from any cause, wichever came first, assesed up to 48 months
Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
Countries
United States, Belgium, Canada, Egypt, France, Ireland, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom