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Protocol # 18-117

Status

Recruiting

Description

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.

Condition

  • Metastatic Castration-Resistant Prostate Cancer

Interventions

  • Onvansertib
  • Abiraterone
  • Prednisone

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Percentage of Participants With Lack of Prostate-specific Antigen (PSA) Progression per Prostate Cancer Working Group 3 (PCWG3) Criteria After 12 Weeks

Secondary Outcome:

  • Percentage Change from Baseline in PSA at 12 Weeks
  • Maximal Percentage Change from Baseline in PSA
  • Absolute Change from Baseline in PSA Response
  • Time to PSA Progression per PCWG3 criteria
  • Time to Radiographic Progression per PCWG3 criteria
  • Radiographic Response per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Percentage of Participants Who are Adherent to Study Treatment (Per-Protocol Analysis) With Lack of Prostate-specific Antigen (PSA) Progression per Prostate Cancer Working Group 3 (PCWG3) Criteria After 12 Weeks
  • Number of Participants With Adverse Events per Common Terminology Criteria for Adverse Events (CTCAE)
  • Number of Participants With Dose Limiting Toxicity (DLT)

Enrollment

88

Study Start Date

June 18, 2018

Eligibility

  • Gender:     Male
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Cardiff Oncology

Source

Cardiff Oncology

Official title

A Phase 2 Study of PCM-075 (Onvansertib) in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prostate Cancer

Clinicaltrials.gov Identifier

NCT03414034

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.