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NCT01928459 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT01928459: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01928459 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 62 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
NCT01928459, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.
Primary Outcome
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisioins.
Interventions
- DRUG BYL719
- DRUG BGJ398
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
What the finished NCT01928459 record still lists
NCT01928459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 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 2 interventions - of which BYL719 is the first listed.
NCT01928459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928459 about?
NCT01928459 is a clinical study titled "Phase 1b Trial of BGJ398/BYL719 in Solid Tumors". To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.
What is the current status of trial NCT01928459?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2013-10. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01928459?
The interventions under investigation include: BYL719 (DRUG), BGJ398 (DRUG).
Who is sponsoring clinical trial NCT01928459?
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 NCT01928459's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 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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