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NCT00265798 · ClinicalTrials.gov registry record · Phase 2
Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate
A Phase 2 study of Gastrointestinal Stromal Tumor, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 6
- Study locations
NCT00265798: Active Phase 2 study of Gastrointestinal Stromal Tumor, sponsored by National Cancer Institute (NCI).
NCT00265798 is a Phase 2 study of Gastrointestinal Stromal Tumor that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 65-participant average among 8 other Gastrointestinal Stromal Tumor trials with a reported enrollment target (42% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00265798, a Phase 2 study of Gastrointestinal Stromal Tumor, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate and sunitinib malate. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Primary Outcome
Objective response (complete response (CR)+ partial response (PR)) will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR is the disappearance of all target lesions. PR requires at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Computed Tomography (CT) scans for disease reassessment will be obtained pre-therapy and every 8 weeks. In addition to a baseline scan, confirmatory scans will a
Conditions Studied
Interventions
- DRUG Sorafenib Tosylate
Study Locations (6)
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- Decatur Memorial Hospital - Decatur
- Central Illinois Hematology Oncology Center - Springfield
California
- City of Hope Comprehensive Cancer Center - Duarte
- University of California Davis Comprehensive Cancer Center - Sacramento
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2005-09-14 |
| Est. Completion | 2026-03-19 |
| Phase | Phase 2 |
What the registry record for NCT00265798 still lists
NCT00265798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 65-participant average among 8 other Gastrointestinal Stromal Tumor trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Gastrointestinal Stromal Tumor appearing as the primary indexed condition, and to 1 intervention - of which Sorafenib Tosylate is the first listed.
NCT00265798 lists 6 locations in 3 states (Illinois, California, New York).
Frequently Asked Questions
What is clinical trial NCT00265798 about?
NCT00265798 is a clinical study titled "Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate". This phase II trial is studying how well sorafenib works in treating patients with malignant gastrointestinal stromal tumor that progressed during or after previous treatment with imatinib mesylate and sunitinib malate. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes nee...
What is the current status of trial NCT00265798?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2005-09-14. Estimated completion is 2026-03-19.
What conditions does trial NCT00265798 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumor.
What interventions are being tested in trial NCT00265798?
The interventions under investigation include: Sorafenib Tosylate (DRUG).
Who is sponsoring clinical trial NCT00265798?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00265798 being conducted?
This trial has 6 study locations across California, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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