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A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer

NCT04019327 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-15

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Karen Autio, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-11
Primary Completion
2025-12-04
Completion
2025-12-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04019327 on ClinicalTrials.gov