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NCT01219699 · ClinicalTrials.gov registry record · Phase 1
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 221
- Enrollment target
NCT01219699: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01219699 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 221 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (268% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01219699, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 221 participants
- Enrollment target
Study Summary
This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene
Primary Outcome
MTD (or RP2D) of oral BYL719 as single agent and in combination with fulvestrant.
Interventions
- DRUG Fulvestrant
- DRUG BYL719
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2010-10-05 |
| Est. Completion | 2020-04-16 |
| Phase | Phase 1 |
What the finished NCT01219699 record still lists
NCT01219699 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (268% higher).
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT01219699 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01219699 about?
NCT01219699 is a clinical study titled "A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene". This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestra...
What is the current status of trial NCT01219699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 221 participants. The study started on 2010-10-05. Estimated completion is 2020-04-16.
What interventions are being tested in trial NCT01219699?
The interventions under investigation include: Fulvestrant (DRUG), BYL719 (DRUG).
Who is sponsoring clinical trial NCT01219699?
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 NCT01219699's enrollment target sits among peer trials
221 230th of 2000 higher than 1,771 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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