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Temozolomide in Unresectable or Metastatic GIST
NCT00005597Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2000
- Primary completion
- Oct 2005
- Countries
- 1
- Sponsor
- SWOG Cancer Research Network
- Modality
- Small Molecules
- Drugs
- temozolomide
- Conditions
- gastrointestinal stromal tumor (GIST)
01
Overview
Phase 2, open-label, single-arm trial of temozolomide in gastrointestinal stromal tumor (GIST), sponsored by SWOG Cancer Research Network. Primary endpoint: Complete and Partial Response at 3 years. Started Apr 2000; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Temozolomide
Temozolomide 200 mg/m^2/day PO on Days 1-5 of each 28 day cycle.
03
Who it enrols
Patients with histologically confirmed unresectable or metastatic GIST, measurable disease, and adequate organ function. Prior imatinib is allowed, but no prior chemotherapy for GIST.
04
Endpoints
Primary
Complete and Partial Response
Secondary
Qualitative or Quantitative Toxic Effects
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