Talazoparib for Advanced Cancer with BRCA Gene Alterations

Palo Alto (17 mi)

Overseen bySarina Piha-Paul, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well talazoparib works in treating patients with cancers that have returned after a period of improvement, do not respond to treatment, or have spread to other parts of the body, and have alterations in the breast cancer, early onset (BRCA) genes. Talazoparib may cause tumor cells to die by blocking an enzyme that protects the tumor cells from damage.

Eligibility Criteria

This trial is for patients with advanced or metastatic cancers that are resistant to standard therapy, have relapsed, and have BRCA gene alterations. They must not be pregnant or breastfeeding, should not have active infections requiring IV antibiotics, and cannot have brain metastases unless stable. Participants need normal blood counts and organ function tests, can't be on recent cancer treatments, must agree to use contraception if applicable.

Inclusion Criteria

I have genetic changes in BRCA1, BRCA2, or related genes.

My advanced cancer did not respond or has come back after standard treatment.

I am fully active or can carry out light work.

Exclusion Criteria

I have not had a stroke, heart attack, or severe chest pain recently.

I do not have an active infection needing IV antibiotics or any other serious illness that requires hospitalization.

I have cancer that has spread to my brain or the membranes around my brain and spinal cord.

I have hepatitis B, C, or HIV.

I have a condition that affects how my body absorbs medication.

I have been treated with a PARP inhibitor before.

Treatment Details

The study is testing Talazoparib's effectiveness in treating various recurrent or refractory cancers with BRCA gene changes. It examines how well this drug causes cancer cells to die by blocking a specific enzyme they need to repair themselves.

1Treatment groups

Experimental Treatment

Group I: Treatment (talazoparib)Experimental Treatment3 Interventions

Patients receive talazoparib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

🇺🇸 Approved in United States as Talzenna for: