Trial intelligence / Profile preview

ZEN003694 and Talazoparib in Recurrent Ovarian Cancer

NCT05071937Phase 2

Key facts

Status: Recruiting
Start: Apr 2023
Primary completion: Nov 2033
Countries: 1
Modality: Small Molecules

Drugs: ZEN3694
Conditions: ovarian cancerprimary peritoneal cancer (PPC)fallopian tube cancer (PFTC)

Overview

Phase 2, open-label, single-arm trial of ZEN3694 in ovarian cancer, primary peritoneal cancer (PPC) and fallopian tube cancer (PFTC). Primary endpoint: Objective Response up to 48 months. Started Apr 2023; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

ZEN003694 + Talazoparib
Experimental arm receiving ZEN003694 and Talazoparib daily in 28-day cycles.

Who it enrols

Female patients >= 18 years with recurrent ovarian, fallopian tube, or primary peritoneal carcinoma, prior PARP inhibitor therapy, ECOG 0-1, and adequate organ function. Excludes patients with prior BET inhibitor treatment, unstable brain metastases, or concurrent use of strong CYP3A4/P-gp inhibitors.

Endpoints

Primary

Objective ResponseUp to 48 months

Secondary

Adverse events at least possibly related to treatmentUp to 48 months
Duration of ResponseUp to 48 months
Progression-free survivalUp to 6 years
Overall survivalUp to 6 years

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