Talazoparib + Temozolomide for Prostate Cancer

Recruiting at 10 trial locations

Overseen By Karen Autio, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: GnRH analogs

Must not be taking: Taxanes, PARP inhibitors

Disqualifiers: Brain metastasis, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Karen Autio, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to castration and has progressed after hormone therapy can join. They need a PSA increase, metastatic disease confirmed by scans, and good organ function. No recent radiation or certain drugs, no genetic mutations in specific DNA repair genes, and no other cancers within the last two years.

Inclusion Criteria

Bilirubin: </= 1.5 ULN (unless documented Gilbert's disease)

Your prostate cancer has been getting worse, as shown by certain tests.

My prostate cancer was confirmed by a lab test.

Exclusion Criteria

I have previously been treated with specific chemotherapy drugs.

I have brain metastasis or active leptomeningeal disease.

I have had radiation therapy within the last 3 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ib Treatment

Participants receive talazoparib and temozolomide to determine the safest dose

Duration not specified

Phase II Treatment

Participants receive talazoparib and temozolomide at the maximum tolerated dose to test efficacy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Talazoparib
• Temozolomide

Trial Overview The trial is testing Talazoparib combined with Temozolomide for safety at the highest dose without severe side effects (1mg Talazoparib & 75mg/m² Temozolomide). Phase II checks how well this combo works against advanced prostate cancer that doesn't respond to hormone therapy.

Participant Groups

Group I: Metastatic Castration Resistant Prostate Cancer Experimental Treatment 2 Interventions

Participants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair

Talazoparib is already approved in United States, European Union for the following indications:

Approved in United States as Talzenna for:

• Deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer

Approved in European Union as Talzenna for:

• Monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+