drugset / Trial / NCT00457743
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-01
- Primary completion
- 2008-08
- Completion
- 2008-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sunitinib | Small molecule | 25 mg | Oral |
| Subject | Sunitinib | Small molecule | 50 mg | Oral |
| Subject | Sunitinib | Small molecule | 75 mg | Oral |