NCT04019327

A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer

A Phase Ib/II Study of Intermittent Talazoparib Plus Temozolomide in Patients With Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine what the safest dose of talazoparib plus temozolomide for participants with metastatic castration resistant prostate cancer. The purpose of Phase II is to test the efficacy (effectiveness) of talazoparib and temozolomide at the maximum tolerated dose, which was determined to be 1mg talazoparib and 75mg/m² temozolomide in the Phase Ib portion of this study.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma
• Prostate Neoplasm
• Prostate Cancer Metastatic
• Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-11
• Primary completion: 2025-12-04
• Completion: 2025-12-04
• First posted: 2019-07-15
• Last updated: 2025-12-15

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study