A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 11, 2019

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2027

Conditions
Prostate CancerProstate AdenocarcinomaProstate NeoplasmProstate Cancer MetastaticCastration-resistant Prostate Cancer
Interventions
DRUG

Talazoparib

"Phase I maximum tolerated dose portion:~Level 1, 2, 3 - 1 mg QD Days 1-6 Level 4, 5 - 1.25 mg QD Days 1-6 Level 6 - 1.5 mg QD Days 1-6"

DRUG

Temozolomide

"Phase I maximum tolerated dose portion:~Level 1 - 37.5 mg/m2 QD Days 2-8 Level 2 - 75 mg/m2 QD Days 2-8 Level 3 \& 4 - 100 mg/m2 QD Days 2-8 Level 5 \& 6 - 125 mg/m2 QD Days 2-8"

Trial Locations (9)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Commack (Limited protocol activity), Commack

18103

Lehigh Valley Health Network (Data Collection Only), Allentown

22908

University of Virginia, Charlottesville

53792

University of Wisconsin, Madison

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT04019327 - A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer | Biotech Hunter | Biotech Hunter