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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after last dose
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of patients who demonstrate simultaneous Rad51 activation
Secondary outcome measures
Overall response rate
Other outcome measures
Tumor genomic alterations potentially associated with sensitivity or acquired resistance to talazoparib
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
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1700
Talazoparib
2021
Completed Phase 2
~2770
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,969 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
A P ChenPrincipal InvestigatorNational Cancer Institute LAO
7 Previous Clinical Trials
554 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your absolute neutrophil count is at least 1,500 per microliter.You are taking any other experimental medications.I am using a reliable birth control method.I can take care of myself but might not be able to do heavy physical work.Your white blood cell count is at least 3,000 per microliter.I have not had chemotherapy or radiotherapy recently.I have received monoclonal antibody therapy recently.I have had cancer other than non-dangerous skin cancer in the last 3 years, but it's under control.You are expected to live for more than 3 months.Your total bilirubin level is not higher than the normal range for the institution, unless you have a specific condition called Gilbert's syndrome or liver metastases.I have a tumor with specific genetic changes and no standard treatment options left.My cancer has specific genetic changes sensitive to PARP inhibitors.I have active brain metastases or carcinomatous meningitis.You have HIV and your viral load is detectable.I am not taking any medications that could interfere with talazoparib.I do not have any unmanaged ongoing illnesses.My cancer has come back or spread to other parts of my body.I can swallow pills whole.My tumor can be safely biopsied.My kidney function is within the safe range for the trial.I have ovarian, pancreatic, breast, gastric, or prostate cancer with specific requirements.I need to take blood thinners like warfarin.I am 18 years old or older.Patients must have a disease that can be measured.You have at least 100,000 platelets per microliter of blood.I have previously been treated with talazoparib.Your hemoglobin level is at least 10 grams per deciliter.Your liver enzymes (AST and ALT) are not more than three times the normal levels.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (talazoparib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment still taking place for this trial?
"As per clinicaltrials.gov, the recruitment process for this research is currently ongoing. It was initially published on December 29th 2020 and has had its most recent update as of July 27th 2022."
Answered by AI
How secure is Biopsy for individuals?
"Due to the limited data available on biopsy's efficacy, our team has assigned it a score of 2 in regards to safety. This is based on its Phase 2 trial status."
Answered by AI
How many participants have been included in this clinical research so far?
"According to the specified criteria, 36 people must participate in this investigation. Subjects can join from different hubs such as University of Florida Health Science Center - Gainesville and University of Oklahoma Health Sciences Centre."
Answered by AI
Could you elaborate on any additional investigations involving Biopsy?
"In 2010, the City of Hope was at the forefront of biopsy research. Since then, 63 trials have concluded and 58 are still active; a majority of these occuring in Gainesville, Florida."
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