Combination of Olaparib and Navitoclax in Women With HGSC and TNBC
Status:
Not yet recruiting
Trial end date:
2025-04-28
Target enrollment:
Participant gender:
Summary
The purpose of this Phase I study is to determine if the PARP inhibitor olaparib can be
safely combined with navitoclax, an inhibitor of Bcl-2/Bcl-XL, in women with TNBC who have
somatic or germline mutations in breast cancer gene one (BRCA1) and breast cancer gene two
(BRCA2) BRCA1/2 or PALB2 and in women with recurrent HGSC who have progressed greater than 6
months since their last platinum containing chemotherapy. The trial is designed as an open-
label multi-center Phase I interventional and translational study. It will identify the
dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and RP2D of olaparib combined
with navitoclax for study in Phase II. There is a plan for a follow on Phase II study
depending on the results obtained during this Phase I trial.The rationale for this study is
that for a subset of patients, olaparib, will increase tumor cell survival dependence on
inhibition of cell death by Bcl 2/Bcl- XL. Thus, navitoclax will augment apoptosis induced by
PARP inhibition with olaparib.