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NCT00441155 · ClinicalTrials.gov registry record · Phase 1
Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib
A Phase 1 study of Gastrointestinal Stromal Tumors, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 4
- Study locations
NCT00441155: Completed Phase 1 study of Gastrointestinal Stromal Tumors, sponsored by Novartis Pharmaceuticals.
NCT00441155 is a Phase 1 study of Gastrointestinal Stromal Tumors that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 14 participants, below the 94-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (85% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00441155, a Phase 1 study of Gastrointestinal Stromal Tumors, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 4
- Study locations
Study Summary
To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST
Primary Outcome
Assessed by AE evaluation, including safety laboratory and cardiac safety (ECG, cardiac enzymes, ECHO) measures.
Conditions Studied
Interventions
- DRUG Nilotinib, Imatinib
Study Locations (4)
Massachusetts
- Dana Farber Cancer Institute - Boston
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Other
- Novartis Investigative Site - Lyon
MI
- Novartis Investigative Site - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2006-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT00441155 record still lists
NCT00441155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 94-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Gastrointestinal Stromal Tumors appearing as the primary indexed condition, and to 1 intervention - of which Nilotinib, Imatinib is the first listed.
NCT00441155 reports a single indexed study location in Massachusetts, Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT00441155 about?
NCT00441155 is a clinical study titled "Patients Completing Core Protocol (CAMN107A2103), Exhibiting Stable Disease (SD), Partial Response (PR) or Complete Response (CR) to Nilotinib in Combination With Imatinib". To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST
What is the current status of trial NCT00441155?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2006-11. Estimated completion is 2011-01.
What conditions does trial NCT00441155 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumors.
What interventions are being tested in trial NCT00441155?
The interventions under investigation include: Nilotinib, Imatinib (DRUG).
Who is sponsoring clinical trial NCT00441155?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00441155 being conducted?
This trial has 4 study locations across Massachusetts, Pennsylvania, MI. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastrointestinal Stromal Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00441155's enrollment target sits among peer trials
14 10th of 10 higher than 1 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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