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NCT00135005 · ClinicalTrials.gov registry record · Phase 1
Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)
A Phase 1 study of Gastrointestinal Stromal Tumors, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 5
- Study locations
NCT00135005: Completed Phase 1 study of Gastrointestinal Stromal Tumors, sponsored by Novartis Pharmaceuticals.
NCT00135005 is a Phase 1 study of Gastrointestinal Stromal Tumors that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 59 participants, below the 89-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (34% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00135005, a Phase 1 study of Gastrointestinal Stromal Tumors, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.
Primary Outcome
MTD is defined to be the highest dose of AMN in combination with imatinib given for at least 21 days in the first treatment cycle
Conditions Studied
Interventions
- DRUG AMN107, STI571
Study Locations (5)
Other
- Novartis Investigative Site - Lyon
- Novartis Investigative Site - Berlin
Massachusetts
- Novartis Investigative Site - Boston
Pennsylvania
- Novartis Investigative Site - Philadelphia
MI
- Novartis Investigative Site - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2005-08 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
What the finished NCT00135005 record still lists
NCT00135005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 89-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Gastrointestinal Stromal Tumors appearing as the primary indexed condition, and to 1 intervention - of which AMN107, STI571 is the first listed.
NCT00135005 lists 5 locations in 4 states (Other, Massachusetts, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT00135005 about?
NCT00135005 is a clinical study titled "Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)". This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resis...
What is the current status of trial NCT00135005?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2005-08. Estimated completion is 2006-11.
What conditions does trial NCT00135005 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumors.
What interventions are being tested in trial NCT00135005?
The interventions under investigation include: AMN107, STI571 (DRUG).
Who is sponsoring clinical trial NCT00135005?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00135005 being conducted?
This trial has 5 study locations across Massachusetts, Pennsylvania, MI. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00135005's enrollment target sits among peer trials
59 4th of 10 higher than 7 of 10 other Gastrointestinal Stromal Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastrointestinal Stromal Tumors 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.
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