Debio 1143 in Combination With Carboplatin and Paclitaxel in Patient With Advanced Solid Malignancies

PHASE1TerminatedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Solid Tumors
Interventions
DRUG

Part A: Debio 1143

Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined.

DRUG

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.

DRUG

Carboplatin

Carboplatin standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle.

DRUG

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.

Trial Locations (4)

21079

Centre Georges François Leclerc, Dijon

31052

Institut Claudius Regaud, Toulouse

69008

Centre Léon Bérard, Lyon

75248

Institut Curie, Paris

Sponsors
All Listed Sponsors
lead

Debiopharm International SA

INDUSTRY