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NCT00471328 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 248
- Enrollment target
NCT00471328 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 248 participants.
The verdict
NCT00471328, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 248 participants
- Enrollment target
Study Summary
The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.
Interventions
- DRUG Nilotinib
- OTHER Best Supportive Care (BSC) +/- imatinib or sunitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00471328
The ClinicalTrials.gov registry entry for NCT00471328 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nilotinib is the first listed.
NCT00471328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00471328 about?
NCT00471328 is a clinical study titled "Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib". The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.
What is the current status of trial NCT00471328?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 248 participants. The study started on 2007-03. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00471328?
The interventions under investigation include: Nilotinib (DRUG), Best Supportive Care (BSC) +/- imatinib or sunitinib (OTHER).
Who is sponsoring clinical trial NCT00471328?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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