31
Participants
Start Date
April 30, 2013
Primary Completion Date
March 31, 2016
Study Completion Date
March 31, 2016
Part A: Debio 1143
Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined.
Paclitaxel
Paclitaxel standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle, after pre-medication to prevent severe hypersensitivity reactions.
Carboplatin
Carboplatin standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle.
Part B: Debio 1143
RD of Debio1143 oral capsules, once daily for five consecutive days starting on day 1 or 2 of each 21-day treatment cycle.
Centre Georges François Leclerc, Dijon
Institut Claudius Regaud, Toulouse
Centre Léon Bérard, Lyon
Institut Curie, Paris
Lead Sponsor
Debiopharm International SA
INDUSTRY