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Clinical Trial Summary

This is a multicenter, randomized, 1:1, double blinded phase II trial. Patients with unresectable malignant pleural mesothelioma (MPM) will be randomized between arm A: nintedanib and arm B:placebo


Clinical Trial Description

This is a multicenter, prospective, double blinded, randomized, two-arm phase II trial aiming to evaluate nintedanib treatment as switch maintenance in patients with unresectable MPM. After signing of the informed consent and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to: - Arm A: twice daily nintedanib at a dose of 200 mg until progression or unacceptable toxicities. - Arm B: matched placebo. Response evaluation will be performed through CT scans every 8 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02863055
Study type Interventional
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 4, 2018
Completion date March 31, 2024

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