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ACTIVE NOT RECRUITING

NCT03395197

PHASE3

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1054

Start Date

2017-12-18

Completion Date

2027-06-30

Last Updated

2026-10-14

Healthy Volunteers

Conditions

mCRPC

Interventions

DRUG

Talazoparib with enzalutamide

Talazoparib 0.5 mg/day plus enzalutamide 160mg/day

DRUG

Placebo with enzalutamide

Placebo plus enzalutamide 160 mg/day

Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be \< 4). For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status Consent to a saliva sample collection for a germline comparator unless prohibited by local regulations or ethics committee decision (optional for patients in Part 1). Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening. Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan. Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria: * Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA values from 3 consecutive assessments with an interval of at least 7 days between assessments.. * Soft tissue disease progression as defined by RECIST 1.1. * Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan. Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2) is allowed but not mandatory. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. Life expectancy ≥ 12 months as assessed by the investigator. Able to swallow the study drug and have no known intolerance to study drugs or excipients. Must agree to use a condom when having sex with a partner from the time of the first dose of study drug through 4 months after last dose of study treatment. Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment when having sex with a non pregnant female partner of childbearing potential. Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug. Evidence of a personally signed and dated informed consent document (and molecular prescreening consent if appropriate) indicating that the patient \[or a legally acceptable representative/legal guardian\] has been informed of all pertinent aspects of the study. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state. Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation. Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer. Prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy within 6 months (from the last dose). Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T, or radionuclide therapy received in the castration-sensitive prostate cancer is NOT exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part 2). Treatment with any investigational agent within 4 weeks before Day 1 (Part 1) or randomization (Part 2). Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2). Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or randomization (Part 2). Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2), or palliative localized radiation therapy within 3 weeks before randomization (Part 2). Clinically significant cardiovascular disease Significant renal dysfunction as defined by any of the following laboratory abnormalities: • Renal: eGFR \< 30 mL/min/1.73 m2 by the MDRD equation (available via www.mdrd.com). Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at screening. Significant hepatic dysfunction as defined by any of the following laboratory abnormalities on screening labs: * Total serum bilirubin \>1.5 times the upper limit of normal (ULN) (\>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation). * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 times ULN (\>5 × ULN if liver function abnormalities are due to hepatic metastasis). * Albumin \<2.8 g/dL Absolute neutrophil count \< 1500/µL, platelets \< 100,000/µL, or hemoglobin \< 9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening). Known or suspected brain metastasis or active leptomeningeal disease. Symptomatic or impending spinal cord compression or cauda equina syndrome. Any history of myelodysplastic syndrome, acute myeloid leukemia, or prior malignancy except any of the following: * Carcinoma in situ or non melanoma skin cancer * Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage. * Stage 0 or Stage 1 cancer \<3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator Gastrointestinal disorder affecting absorption. Fertile male subjects who are unwilling or unable to use highly effective methods of contraception for the duration of the study and for 4 months after the last dose of investigational product. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study. Other acute or chronic medical (concurrent disease, infection, or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that interferes with ability to participate in the study, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization (Part 2).

Locations (370)

Alaska Urological Institute dba Alaska Clinical Research Center

Anchorage, Alaska, United States

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

Chandler, Arizona, United States

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

Gilbert, Arizona, United States

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

Mesa, Arizona, United States

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

Mesa, Arizona, United States

Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers

Scottsdale, Arizona, United States

Arizona Urology Specialists

Tucson, Arizona, United States

Arizona Urology Specialists

Tucson, Arizona, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

South County Hematology/Oncology

Chula Vista, California, United States

Sharp Rees-Stealy

Chula Vista, California, United States

Glendale Adventist Medical Center

Glendale, California, United States

Marin Cancer Care, Inc.

Greenbrae, California, United States

Cancer Center Oncology Medical Group

La Mesa, California, United States

Loma Linda University Cancer Center - Records Management Only

Loma Linda, California, United States

Loma Linda University Cancer Center - Hematology/Oncology Clinic

Loma Linda, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

VA Long Beach Healthcare System

Long Beach, California, United States

UCLA Clark Urology Center

Los Angeles, California, United States

University of California, Irvine Medical Center

Orange, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

Desert Hematology Oncology Medical Group, Incorporation

Rancho Mirage, California, United States

Eisenhower Medical Center

Rancho Mirage, California, United States

Medical Oncology Associates-SD

San Diego, California, United States

Sharp Memorial Hospital Investigational Pharmacy

San Diego, California, United States

Sharp Rees-Stealy

San Diego, California, United States

Stanford Health Care

Stanford, California, United States

University of Colorado Denver CTO/CTRC

Aurora, Colorado, United States

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States

University of Colorado Hospital- Anschutz Inpatient Pavilion

Aurora, Colorado, United States

University of Colorado Hospital- Anschutz Outpatient Pavilion

Aurora, Colorado, United States

University of Colorado Hospital

Aurora, Colorado, United States

The Urology Center of Colorado

Denver, Colorado, United States

Florida Cancer Specialists

Altamonte Springs, Florida, United States

Florida Cancer Specialists

Brandon, Florida, United States

Florida Cancer Specialists

Clearwater, Florida, United States

Florida Cancer Specialists

Daytona Beach, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Cancer Specialists

Gainesville, Florida, United States

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

Florida Cancer Specialists

Largo, Florida, United States

Florida Cancer Specialists

Lecanto, Florida, United States

Florida Cancer Specialists

New Port Richey, Florida, United States

Florida Cancer Specialists

Ocala, Florida, United States

Florida Cancer Specialists

Orange City, Florida, United States

AdventHealth Medical Group Hermatology and Oncology

Orlando, Florida, United States

Investigational Drug Services, Advent Health Orlando

Orlando, Florida, United States

Florida Cancer Specialists

Orlando, Florida, United States

Florida Cancer Specialists

Spring Hill, Florida, United States

Florida Cancer Specialists

St. Petersburg, Florida, United States

Florida Cancer Specialists

Stuart, Florida, United States

Florida Cancer Specialists

Tampa, Florida, United States

Florida Cancer Specialists

Tavares, Florida, United States

Florida Cancer Specialists

The Villages, Florida, United States

Florida Cancer Specialists

Vero Beach, Florida, United States

Florida Cancer Specialists

Wellington, Florida, United States

Florida Cancer Specialists

West Palm Beach, Florida, United States

Florida Cancer Specialists

Winter Park, Florida, United States

Piedmont Cancer Institute

Atlanta, Georgia, United States

Piedmont Cancer Institute

Fayetteville, Georgia, United States

Piedmont Cancer Institute

Newnan, Georgia, United States

Southeastern Regional Medical Center

Newnan, Georgia, United States

Cook County Health (CCH)

Chicago, Illinois, United States

John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy

Chicago, Illinois, United States

AMITA Health Adventist Medical Center Hinsdale

Hinsdale, Illinois, United States

AMITA Health Cancer Institute

Hinsdale, Illinois, United States

Midwestern Regional Medical Center

Zion, Illinois, United States

Clark Memorial Hospital Radiology

Jeffersonville, Indiana, United States

First Urology, PSC

Jeffersonville, Indiana, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

The University of Kansas Clinical Research Center

Fairway, Kansas, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

VA Saint Louis Healthcare System

St Louis, Missouri, United States

XCancer Omaha / Urology Cancer Center, PC d/b/a XCancer

Omaha, Nebraska, United States

Clara Maass Medical Center

Belleville, New Jersey, United States

New Jersey Cancer Care and Blood Disorders

Belleville, New Jersey, United States

University Radiology

Nutley, New Jersey, United States

New Jersey Urology, LLC

Voorhees Township, New Jersey, United States

Urology Group of New Mexico

Albuquerque, New Mexico, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

Premier Medical Group of the Hudson Valley PC

Poughkeepsie, New York, United States

Associated Medical Professionals of New York, PLLC

Syracuse, New York, United States

Montefiore Medical Center - Montefiore Medical Park

The Bronx, New York, United States

TriState urologic Services PSC Inc., dba The Urology Group

Cincinnati, Ohio, United States

Clinical Research Solutions

Middleburg Heights, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Kaiser Sunnyside Medical Center

Clackamas, Oregon, United States

Kaiser Westside Medical Center

Hillsboro, Oregon, United States

Providence Cancer Institute Newberg Clinic

Newberg, Oregon, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Cancer Institute Willamette Falls

Oregon City, Oregon, United States

Providence Cancer Institute Franz Clinic