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NCT01468688 · ClinicalTrials.gov registry record · Phase 1
A Dose-finding Study of a Combination of Imatinib and BKM120 in the Treatment of 3rd Line GIST Patients
A Phase 1 study of 3rd Line GIST, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 11
- Study locations
NCT01468688: Completed Phase 1 study of 3rd Line GIST, sponsored by Novartis Pharmaceuticals.
NCT01468688 is a Phase 1 study of 3rd Line GIST that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 11 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01468688, a Phase 1 study of 3rd Line GIST, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.
Primary Outcome
Dose limiting toxicity (DLT) will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) (v4.0.3), unless otherwise specified in the protocol.
Conditions Studied
Interventions
- DRUG BKM120
- DRUG STI571
Study Locations (11)
Other
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Lyon
- Novartis Investigative Site - Villejuif
- Novartis Investigative Site - Leiden
- Novartis Investigative Site - London
- Novartis Investigative Site - Manchester
Massachusetts
- Dana Farber Cancer Institute SC (2) - Boston
Washington
- Seattle Cancer Care Alliance Onc - Seattle
British Columbia
- Novartis Investigative Site - Vancouver
Chiba
- Novartis Investigative Site - Kashiwa
Catalonia
- Novartis Investigative Site - Barcelona
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-04-20 |
| Est. Completion | 2016-07-29 |
| Phase | Phase 1 |
What the finished NCT01468688 record still lists
NCT01468688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with 3rd Line GIST appearing as the primary indexed condition, and to 2 interventions - of which BKM120 is the first listed.
NCT01468688 lists 11 locations in 6 states (Other, Massachusetts, Washington).
Frequently Asked Questions
What is clinical trial NCT01468688 about?
NCT01468688 is a clinical study titled "A Dose-finding Study of a Combination of Imatinib and BKM120 in the Treatment of 3rd Line GIST Patients". The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BKM120 in the treatment of 3rd line GIST patients.
What is the current status of trial NCT01468688?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-04-20. Estimated completion is 2016-07-29.
What conditions does trial NCT01468688 study?
This clinical trial studies the following conditions: 3rd Line GIST.
What interventions are being tested in trial NCT01468688?
The interventions under investigation include: BKM120 (DRUG), STI571 (DRUG).
Who is sponsoring clinical trial NCT01468688?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01468688 being conducted?
This trial has 11 study locations across Massachusetts, Washington, British Columbia, Chiba, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01468688's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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