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Nintedanib Maintenance in Pleural Malignant Mesothelioma
NCT02863055Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2018
- Primary completion
- Oct 2023
- Countries
- 3
- Sponsor
- European Organisation for Research and Treatment of Cancer
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Drugs
- nintedanib
- Conditions
- malignant pleural mesothelioma (MPM)
01
Overview
Phase 2, randomised, double-blind trial in malignant pleural mesothelioma (MPM) comparing Nintedanib with Placebo (2 arms). Primary endpoint: Progression-free survival at 6 months. Started Feb 2018; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nintedanib
Nintedanib 200 mg twice daily
Placebo
Matching placebo twice daily
03
Who it enrols
Patients with unresectable Malignant Pleural Mesothelioma who achieved response or stable disease after 4-6 cycles of first-line platinum-pemetrexed chemotherapy.
04
Endpoints
Primary
Progression-free survival
Secondary
Overall survival
Overall Response Rate
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