The Exactis-03 trial “A Phase I/II Basket Trial of the Combination of PARP inhibitor and Navitoclax in Women with High Grade Serous Epithelial Ovarian Cancer and Triple Negative Breast Cancer” led by Dr. Helen MacKay from Sunnybrook Hospital, will be opened across PMT Network sites and Princess Margaret Hospital.
Phase I will define the dose and schedule of navitoclax that can be combined safely with PARP inhibitor in women with TNBC and HGSC.
Phase II will evaluate the antitumor activity of the combination of PARP inhibitor and navitoclax, based on objective response rate, for the treatment of metastatic women with recurrent HGSC and HRD metastatic TNBC. Each cohort will enroll up to 30 patients during phase II.
Biopsies pre-PARP inhibitor and pre-navitoclax as well as serial blood samples will be collected for exploratory correlative studies including including the investigation of the potential relationship between biomarkers like tumoral DNA damage or Bcl2/Bcl-xl or ctDNA and outcomes. We anticipate study start in Fall 2020.