Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer

Phase 2 Completed 72 enrolled Cardiff Oncology

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2018-08-14
Primary completion: 2023-10-16
Completion: 2023-10-16

Outcome

Met primary endpoint

release “60% of patients completing 3 months of treatment and evaluable for efficacy achieved the primary endpoint of disease control.” cardiffoncology.com ↗

Publications

Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Onvansertib	Small molecule	12 mg/m2	Oral
Subject	Onvansertib	Small molecule	24 mg/m2	Oral
Background	Abiraterone acetate	Small molecule	—	Oral
Background	Prednisone	Other / unclassified	—	Oral