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NCT02379247 · ClinicalTrials.gov registry record · Phase 1
BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer
A Phase 1 study, sponsored by Priyanka Sharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02379247: Completed Phase 1 study, sponsored by Priyanka Sharma.
NCT02379247 is a Phase 1 study that has completed, run by Priyanka Sharma. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02379247, a Phase 1 study, has completed, sponsored by Priyanka Sharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
Investigate the use of BYL719 (alpelisib) as combination therapy with Nab-Paclitaxel in locally recurrent or metastatic HER-2 negative breast cancer.
Primary Outcome
Phase I was a 3+3 dose escalation design (three dose levels of alpelisib: 250mg, 300mg, and 350mg orally once daily, continuous dosing) with dose-limiting toxicities (DLT) assessed during the first treatment cycle. If two or more of the six patients experienced a dose-limiting toxicity, dosing escalation would cease and maximum tolerated dose (MTD) would be reached. RP2D was the next lower dose at which \<1/6 subjects experienced a DLT.
Interventions
- DRUG Nab-paclitaxel
- DRUG BYL-719 (alpelisib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2015-02 |
| Est. Completion | 2022-03 |
| Phase | Phase 1 |
What the finished NCT02379247 record still lists
NCT02379247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Nab-paclitaxel is the first listed.
NCT02379247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02379247 about?
NCT02379247 is a clinical study titled "BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer". Investigate the use of BYL719 (alpelisib) as combination therapy with Nab-Paclitaxel in locally recurrent or metastatic HER-2 negative breast cancer.
What is the current status of trial NCT02379247?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2015-02. Estimated completion is 2022-03.
What interventions are being tested in trial NCT02379247?
The interventions under investigation include: Nab-paclitaxel (DRUG), BYL-719 (alpelisib) (DRUG).
Who is sponsoring clinical trial NCT02379247?
This trial is sponsored by Priyanka Sharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02379247's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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