Efficacy and Safety of PD-0332991 in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

December 31, 2016

Study Completion Date

February 28, 2019

Conditions
Advanced Gastrointestinal Stromal Tumors
Interventions
DRUG

PD 0332991

"PD-0332991 was administrated orally, formulated as gelatin capsules of 100 mg and 25 mg respectively.~PD-0332991 was dosed on a flat scale of 125 mg (1 capsule x 100 mg/day, 1 capsule x25 mg/day) will be administrated orally o.d on a 21 days on / 7 days off dosing schedule. One cycle is considered to consist of 4 weeks of PD-0332991 administration.~Patients should be instructed to administrate PD-0332991 with a sufficient amount of water at least 1 hour prior to a meal or at least 2 hours following a meal and to swallow the required number of capsules at approximately the same time on each day."

Trial Locations (9)

13385

Hôpital de la Timone - AP-HM, Marseille

21079

Centre Georges-Francois Leclerc, Dijon

33076

Institut Bergonié, Bordeaux

44805

Centre René Gauducheau, Nantes

51092

CHU de REIMS - Hôpital Robert Debré, Reims

59020

Centre Oscar Lambret, Lille

69373

Centre Léon Bérard, Lyon

75571

Hôpital Saint-Antoine (AP-HP), Paris

94800

Institut Gustave Roussy, Villejuif

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Institut Bergonié

OTHER