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PARP Inhibitor

Talazoparib for Advanced Cancer with BRCA Gene Alterations

Phase 2

Waitlist Available

Led By Sarina A Piha-Paul

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have somatic mutations or deletions in BRCA1 or BRCA2, genomic alterations in other BRCA pathway genes, or germline mutation in BRCA1 or BRCA2 (not breast or ovarian cancer)

Patients with advanced or metastatic cancer that is refractory to standard therapy or has relapsed after standard therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial studies talazoparib for patients with cancer that has returned or progressed after treatment. Talazoparib may cause cancer cells to die by blocking an enzyme that protects them from damage.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the trial description does not list specific side effects of Talazoparib, similar drugs often cause fatigue, nausea, blood cell count issues (like anemia), digestive problems (such as vomiting), and increased risk of infection due to weakened immune systems.

Eligibility Criteria

Inclusion Criteria

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

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

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

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical benefit by Response Evaluation Criteria in Solid Tumors 1.1

Secondary outcome measures

Duration of response

Overall survival

Progression free survival

Other outcome measures

Archival immunohistochemistry staining

BRCA1/2 alterations in archival tissue

BRCA1/2 alterations in pretreatment biopsies

+7 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

2021

Completed Phase 2

~2770

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,087 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,491 Total Patients Enrolled

Sarina A Piha-PaulPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

300 Total Patients Enrolled

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02286687 — Phase 2

Cancer Research Study Groups: Treatment (talazoparib)

Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT02286687 — Phase 2

Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02286687 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently participating in this clinical investigation?

"This clinical trial has concluded its recruitment process, with the original posting on December 22nd 2014 and the most recent editing occuring February 21st 2022. However, there are still 3307 trials enrolling patients with metastatic malignant neoplasms and 58 studies for Talazoparib accepting participants."

Answered by AI

Are there any available slots in this research initiative for participants?

"Unfortunately, no further recruitment is being conducted for this trial. It was initially launched on December 22nd 2014 and the most recent edit occurred on February 21st 2022. However, if you are in search of other studies, 3307 clinical trials focusing on metastatic malignant neoplasm are currently accepting participants along with 58 separate evaluations that involve Talazoparib."

Answered by AI

What is the known risk profile of taking Talazoparib?

"The safety rating for Talazoparib is estimated to be 2, as the trial it's currently in has only provided evidence of its security and not yet its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes

2014. "Talazoparib in Treating Patients With Recurrent, Refractory, Advanced, or Metastatic Cancers and Alterations in the BRCA Genes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02286687.