Combination of Olaparib and Navitoclax in Women with HGSC and TNBC

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 9, 2022

Primary Completion Date

March 30, 2025

Study Completion Date

April 28, 2025

Conditions
High Grade Serous CarcinomaTriple Negative Breast CancerOvarian Cancer
Interventions
DRUG

Olaparib tablet

Olaparib tablet will be administered alone for 14 days at a starting dose of 200 mg twice daily. Subsequently olaparib will be administered continuously over 28 days at a fixed dose and the dose of navitoclax will be escalated.

DRUG

Navitoclax

For navitoclax, a lead-in of 7 days at 150 mg PO will be used prior to dose escalation. The DLT period for dose levels above DL 3 will include the 14-day olaparib alone lead-in, the 7 days combination with navitoclax at 150 mg and the first 28 day cycle of the combination of olaparib and navitoclax cycle at the full dose level dosing (49 days).

Trial Locations (3)

M4N 3M5

Sunnybrook Research Institute/Odette Cancer Centre, Toronto

M5G 1Z5

Princess Margaret Cancer Centre, Toronto

H2X 0A9

CHUM, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Exactis Innovation

OTHER

collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

collaborator

Princess Margaret Hospital, Canada

OTHER

lead

Sunnybrook Health Sciences Centre

OTHER

NCT05358639 - Combination of Olaparib and Navitoclax in Women with HGSC and TNBC | Biotech Hunter | Biotech Hunter