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NCT01735968 · ClinicalTrials.gov registry record · Phase 1
A Dose-finding Study of a Combination of Imatinib and BYL719 in the Treatment of 3rd Line GIST Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT01735968: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01735968 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01735968, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
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 BYL719 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.
Interventions
- DRUG ST571 + BYL719
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2013-02-27 |
| Est. Completion | 2018-10-19 |
| Phase | Phase 1 |
What the finished NCT01735968 record still lists
NCT01735968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 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 0 conditions, and to 1 intervention - of which ST571 + BYL719 is the first listed.
NCT01735968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01735968 about?
NCT01735968 is a clinical study titled "A Dose-finding Study of a Combination of Imatinib and BYL719 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 BYL719 in the treatment of 3rd line GIST patients.
What is the current status of trial NCT01735968?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2013-02-27. Estimated completion is 2018-10-19.
What interventions are being tested in trial NCT01735968?
The interventions under investigation include: ST571 + BYL719 (DRUG).
Who is sponsoring clinical trial NCT01735968?
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 NCT01735968's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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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