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

Trial ID # NCT01623349
Phase I
Drug Class Signaling Pathway Inhibitors: PI3K-AKT-mTOR/PI3Kalpha
Drug Name Alpelisib
Alternate Drug Names PI3K inhibitor BYL719, BYL719, phosphoinositide 3-Kinase inhibitor BYL719, Piqray
Drugs in Trial Alpelisib, Olaparib
Eligible Participant

Advanced solid tumors (OvCa: HGS or gBRCA MUT of any histology)

Patients Enrolled

118 [28 ovarian; 21 HGS, 5 poorly differentiated adenocarcinoma NOS, 1 carcinosarcoma, 1 mixed HGS and transitional cell carcinoma; median 3 prior therapies (2-5)]

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, DCR, DoR, PFS, OS, RP2D, evaluated per RECIST


Exploratory: gBRCA1/2


RP2D: Alp 200 mg qd and Ola 200 mg bid
ORR: 36% (10PR, n=28) (93% Pt-R/Pt-Rf)
ORR: 34.6% (9PR, n=26) (all Pt-R/Pt-Rf)
DCR: 86% (10PR, 14SD, n=28)
DoR: 5.5 months (0.5-13.2)
PFS: 7.2 months (4.9-9.0)
OS: 21.3 months (11.4-23.7)

Exploratory analysis BRCA status in Pt-R/Pt-Rf patients:
gBRCA WT: ORR: 31.3% (5PR, n=16)
gBRCA MUT: ORR: 33.3% (3PR, n=9)
BRCA WT: ORR: 33.3% (4PR, n=12)
BRCA MUT: ORR: 30.8% (4PR, n=13)

Clinically Significant Adverse Events

Dose Limiting Toxicities: hyperglycemia (n=2), rash (n=1), neutropenia and fever (n=1)
Serious AE: none
Grade 3-4 AE: hyperglycemia (16%)


Encouraging activity of alpelisib+olaparib combination, also in BRCA WT patients


Konstantinopoulos PA et al. Olaparib and alpha-specific PI3K inhibitor alpelisib for patients with epithelial ovarian cancer: a dose escalation and dose-expansion phase 1b trial. Lancet (2019) 20(4):570-580

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