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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: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00471328 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 248 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-free survival (PFS) is the time from date of randomization to the date of first documented progression or death due to any cause. If a participant has not had an event, progression-free survival is censored at the time of last adequate tumor assessment. Progression is defined according to Modified Response Evaluation Criteria in Solid Tumors (modified RECIST) criteria as at least a 20% increase in the sum of the longest diameter of target lesions, worsening of the non-target lesions
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 |
What the finished NCT00471328 record still lists
NCT00471328 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Nilotinib is the first listed.
NCT00471328 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00471328's enrollment target sits among peer trials
248 1266th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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