Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: PLK1 PLK Inhibitor Onvansertib
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

Brief summary:
The purpose of the phase 2 study is to determine whether Onvansertib is safe and tolerable in adult participants with Metastatic Castration-Resistant Prostate Cancer who have disease progression while receiving abiraterone acetate (abiraterone) and prednisone therapy, and to observe the effects of Onvansertib in combination with abiraterone and prednisone on disease control.

Detailed description:

Arms:
arm 1: On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone. This arm was discontinued. arm 2: On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 24 mg/m\^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone. arm 3: On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 12 mg/m\^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone.

Interventions: intervention 1: Onvansertib intervention 2: Abiraterone intervention 3: Prednisone
Intervention descriptions: intervention 1: Onvansertib orally intervention 2: Abiraterone orally intervention 3: Prednisone orally

Protocol document:
Prot_000.pdf: 
Protocol Number: TROV-053 
Official Title: A Phase 2 Study of Onvansertib (PCM-075) in Combination with Abiraterone and 
Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer 
NCT Number: NCT03414034 
Document Date: 16 Nov 2020 

















































































































































SAP_001.pdf: 
Protocol Number: TROV-053 
Official Title: A Phase 2 Study of Onvansertib (PCM-075) in Combination with Abiraterone and 
Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer 
NCT Number: NCT03414034
Document Date: 23 May 2023