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NCT00785785 · ClinicalTrials.gov registry record · Phase 3
A Study of Nilotinib Versus Imatinib in GIST Patients
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 644
- Enrollment target
NCT00785785: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00785785 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 644 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00785785, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 644 participants
- Enrollment target
Study Summary
This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
Primary Outcome
PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Interventions
- DRUG Nilotinib (AMN107)
- DRUG imatinib (STI571)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2009-03 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT00785785 record still lists
NCT00785785 is an interventional study that assigns participants to a tested intervention. The registered 644 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 (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Nilotinib (AMN107) is the first listed.
NCT00785785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00785785 about?
NCT00785785 is a clinical study titled "A Study of Nilotinib Versus Imatinib in GIST Patients". This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).
What is the current status of trial NCT00785785?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2009-03. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00785785?
The interventions under investigation include: Nilotinib (AMN107) (DRUG), imatinib (STI571) (DRUG).
Who is sponsoring clinical trial NCT00785785?
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 NCT00785785's enrollment target sits among peer trials
644 572nd of 2000 higher than 1,428 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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