Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

Official Title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Summary:

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Trial Description

Primary Outcome:

• Confirm the dose of Talazoparib (part 1)
• Radiographic PFS (part 2) in unselected patients and in patients harboring DDR deficiencies

Secondary Outcome:

• Overall survival (part 2) in unselected patients and in patients harboring DDR deficiencies
• Objective response in measurable soft tissue disease (part 2) in unselected patients and in patients harboring DDR deficiencies
• Duration of soft tissue response (part 2) in unselected patients and in patients harboring DDR deficiencies
• PSA response (part 2) in unselected patients and in patients harboring DDR deficiencies
• Time to PSA progression (part 2) in unselected patients and in patients harboring DDR deficiencies
• Time to initiation of cytotoxic chemotherapy (part 2) in unselected patients and in patients harboring DDR deficiencies
• Time to initiation of antineoplastic therapy (part 2) in unselected patients and in patients harboring DDR deficiencies
• Time to first symptomatic skeletal event (part 2) in unselected patients and in patients harboring DDR deficiencies
• PFS on next line of therapy (PFS2) in unselected patients and in patients harboring DDR deficiencies
• Opiate use for cancer pain (part 2) in unselected patients and in patients harboring DDR deficiencies
• Incidence of adverse events (part 1 and 2)
• Pharmacokinetic assessment of talazoparib (part 1)
• Pharmacokinetic assessment of talazoparib (part 2)
• Pharmacokinetic assessment of enzalutamide (part 1)
• Pharmacokinetic assessment of enzalutamide (part 2)
• Patient-reported outcome:pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
• Patient-reported outcome: pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
• Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
• Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
• Patient-reported outcome: general health status (part2) in unselected patients and patients harboring DDR deficiencies
• Patient-reported outcome: general health status (part 2) in unselected patients and patients harboring DDR deficiencies

Part 1 is an open-label, non-randomized, safety and PK run-in study designed to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and PK at select sites. Part 2 is a randomized, double-blind, placebo-controlled, multinational study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide in patients with mCRPC.

View this trial on ClinicalTrials.gov