Trials / Completed
CompletedNCT00457743
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sunitinib malate (SU011248) | SU011248 |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2007-04-06
- Last updated
- 2009-11-13
- Results posted
- 2009-11-13
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00457743. Inclusion in this directory is not an endorsement.