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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

Status: Recruiting
Phase: Phase 1
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01623349 (View complete trial on
DFCI Protocol ID: 12-159


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.


Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Ursula Matulonis, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Gerburg Wulf, MD, Beth Israel Deaconess Medical Center
Michael Birrer, MD, PhD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Histologically or cytologically confirmed recurrent high grade serous ovarian cancer or triple negative breast cancer - Subjects with recurrent, metastatic triple negative breast cancer must have had at least 1 chemotherapy regimen for metastatic breast cancer or have developed metastatic breast cancer within 1 year of completion of adjuvant chemotherapy - Prior therapy for high grade serous ovarian cancer subjects must have included a first-line platinum-based regimen - At least 4 weeks since prior radiation therapy, 3 weeks since prior chemotherapy and 6 weeks if the last regimen included BCNU or mitomycin C - At least 4 weeks since any small-molecular kinase inhibitors or any other type of investigational agent - Life expectancy of at least 4 months - Able to swallow and tolerate oral medications Exclusion Criteria: - Evidence of bowel obstruction, abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of study entry - Current dependency on IV hydration or total parental nutrition - Diabetes mellitus unless well controlled - Pregnant or breast feeding - History of grade 3 or 4 toxicities with previous PI3kinase inhibitor or PARP inhibitor - Current or active dermatologic diagnoses that would preclude interpretation of skin toxicities of BKM120 - Receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 - History of cardiac dysfunction or disease - Persistent toxicities (greater than or equal to CTCAE grade 2) caused by previous cancer therapy - Major surgery within 14 days of starting study treatment - Evidence of coagulopathy or bleeding diathesis - History of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, history of suicide attempt or ideation or homicide/homicidal ideation - CTCAE grade 3 or greater anxiety - Uncontrolled, intercurrent illness - Known HIV positive and on combination antiretroviral therapy - Receiving chronic treatment with steroids or another immunosuppressive agent
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