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NCT01623349 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 118
- Enrollment target
NCT01623349: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT01623349 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 118 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01623349, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 118 participants
- Enrollment target
Study Summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination to use for further studies. "Investigational" means that the combination of these drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved either of these drugs nor the combination of being tested for use in patients, including people with your type of cancer. BKM120, BYL719 and olaparib are drugs that may stop cancer cells from growing abnormally. These drugs when combined in laboratory experiments with animals, have demonstrated anti-cancer activity. Information from these other research studies suggests that the following agents BKM120, BYL719 and olaparib, may help to shrink tumor cells in the types of cancers being studied in this research study. In this research study, the investigators are looking for the highest dose that can be given safely and also to see if the combination of BKM120 or BYL719 and olaparib is effective in treating your type of cancer.
Primary Outcome
To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of BKM120 and olaparib, and the combination of BYL719 and olaparib in patients with recurrent TNBC and HGSC.
Interventions
- DRUG BKM120 and Olaparib
- DRUG BYL719 and Olaparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2012-09 |
| Est. Completion | 2020-12 |
| Phase | Phase 1 |
What the finished NCT01623349 record still lists
NCT01623349 is an interventional study that assigns participants to a tested intervention. The registered 118 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 (97% higher).
The record links to 0 conditions, and to 2 interventions - of which BKM120 and Olaparib is the first listed.
NCT01623349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01623349 about?
NCT01623349 is a clinical study titled "Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer". This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination to use for further studies. "Investigational" means that the combination of ...
What is the current status of trial NCT01623349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2012-09. Estimated completion is 2020-12.
What interventions are being tested in trial NCT01623349?
The interventions under investigation include: BKM120 and Olaparib (DRUG), BYL719 and Olaparib (DRUG).
Who is sponsoring clinical trial NCT01623349?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01623349's enrollment target sits among peer trials
118 499th of 2000 higher than 1,502 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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