CX-5461/Talazoparib-Metastatic Castration Resistant Prostate Cancer
Study Focus
CX-5461/Talazoparib-Metastatic Castration Resistant Prostate Cancer
Protocol Number
20/019
Sponsor
Peter MacCallum Cancer Centre
Requestor
Peter MacCallum Cancer Centre
Estimated Enrollment
48
Objective
Primary Objective:
To establish the maximum tolerated dose (MTD), dose limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of pidnarulex in combination with talazoparib in patients with metastatic castration resistant prostate cancer (mCRPC).
Secondary Objectives:
To evaluate the safety of pidnarulex in combination with talazoparib in patients with mCRPC
To evaluate the anti-tumour activity of pidnarulex in combination with talazoparib in patients with mCRPC by the following assessments: To evaluate the rate of treatment discontinuation due to toxicity
50% prostate specific antigen (PSA) response rate (PSA-RR)
Radiographic progression-free survival (rPFS)
PSA progression free survival (PSA-PFS)
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 in patients with measurable disease
Overall survival (OS)
Duration of response (DOR)
Time to treatment response (TTR) in the subset of patients who achieved a 50% PSA response
To evaluate the rate of treatment discontinuation due to toxicity