NCT01623349View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

118

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

May 31, 2019

Study Completion Date

December 31, 2020

Conditions
Ovarian CancerBreast Cancer
Interventions
DRUG

BKM120 and Olaparib

Olaparib twice daily (starting dose 50 mg) and BKM120 once daily (starting dose 40 mg). Both drugs are given orally.

DRUG

BYL719 and Olaparib

Olaparib twice daily (starting dose 100 mg) and BYL719 once daily (starting dose 250 mg). Both drugs are given orally.

Trial Locations (5)

10065

Memorial Sloan-Kettering Cancer Center, New York

77230

MD Anderson Cancer Center, Houston

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (2)

Novartis
AstraZeneca
All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER