Last updated on August 2018

Nintedanib as Switch Maintenance Treatment of Pleural Malignant Mesothelioma

Brief description of study

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

Detailed Study 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.

Clinical Study Identifier: NCT02863055

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Recruitment Status: Open

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