Conditions: Gastrointestinal Stromal Tumors
Keywords: Evaluate of RTD for Japanese GIST patients
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.

Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.

Detailed description:

Arms:
arm 1: 25 , 50 or 75 mg/day of SU011248

Interventions: intervention 1: Sunitinib malate (SU011248)
Intervention descriptions: intervention 1: SU011248

Protocol document: