Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

Active:	No
Cancer Type:	Prostate Cancer Unknown Primary	NCT ID:	NCT04821622
Trial Phases:	Phase III	Protocol IDs:
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	Pfizer Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT04821622

Summary

The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination
with enzalutamide compared with placebo in combination with enzalutamide in participants with
DDR-deficient mCSPC.

Objectives

The study will have 5 periods: prescreening, screening, double-blind treatment, safety
follow-up, and long-term follow-up.

Approximately 550 men with mCSPC will be randomized. Eligible participants will be randomly
assigned to either of 2 treatment groups as follows:

- Talazoparib in combination with enzalutamide.

- Placebo capsules identical in appearance to talazoparib capsules in combination with
enzalutamide.

Talazoparib or identical placebo treatment will be blinded. Enzalutamide (160 mg/day) will be
open label. The dose of talazoparib/placebo to be given in combination with enzalutamide is
0.5 mg once daily. Participants with moderate renal impairment (eGFR 30-59 mL/min/1.73 m2 by
the MDRD equation) at screening may be enrolled and the talazoparib/placebo dose will be 0.35
mg once daily.

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell
1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Doctors:

Sujatha Hariharan MD

Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen
200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton
157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville
100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Doctors:

Satyen R. Mehta MD

Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville
6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Doctors:

Navin P. Wadehra MD

Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper
1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta
340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Paulding
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD

Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica
705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Doctors:

Randall E. Pierce MD

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.