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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 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 118 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01623349
The ClinicalTrials.gov registry entry for NCT01623349 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BKM120 and Olaparib is the first listed.
NCT01623349 reports 0 study locations.
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.
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