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PARP Inhibitor

Talazoparib for Advanced Cancer

Phase 2

Recruiting

Led By A P Chen

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women of child-bearing potential must agree to use a highly effective method of contraception

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Must not have

Patients who have had prior monoclonal antibody therapy within specified timeframes

Patients with active brain metastases or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if talazoparib works in patients with advanced cancer who have mutations in their DNA repair genes. Talazoparib is a drug that blocks PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die.

Who is the study for?

Adults with advanced cancer and specific DNA repair gene mutations, who have progressed after standard therapy or lack treatment options. They must be able to swallow pills, have a life expectancy over 3 months, acceptable blood counts and organ function, and women must use contraception. Excluded are those with HIV, recent chemotherapy or radiotherapy, lactating women, pregnant women, prior talazoparib treatment.

What is being tested?

The trial is testing Talazoparib's effectiveness in patients with advanced cancers that have spread and contain DNA repair gene mutations. It involves taking the drug to see if it prevents cancer cells from repairing their DNA damage which may lead to cell death.

What are the potential side effects?

Talazoparib can cause blood cell count changes leading to increased infection risk or bleeding problems; fatigue; nausea; vomiting; hair loss; kidney function changes; potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am using a reliable birth control method.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer has specific genetic changes sensitive to PARP inhibitors.

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My cancer has come back or spread to other parts of my body.

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I can swallow pills whole.

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My tumor can be safely biopsied.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received monoclonal antibody therapy recently.

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I have active brain metastases or carcinomatous meningitis.

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I do not have any unmanaged ongoing illnesses.

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I need to take blood thinners like warfarin.

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I have previously been treated with talazoparib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of patients who demonstrate simultaneous Rad51 activation

Secondary study objectives

Overall response rate

Other study objectives

Tumor genomic alterations potentially associated with sensitivity or acquired resistance to talazoparib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (talazoparib)Experimental Treatment5 Interventions

Patients receive talazoparib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo biopsy and blood sample collection throughout the study. Patients undergo CT scan or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Computed Tomography

2017

Completed Phase 2

~2740