Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
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ClinicalTrials.gov Identifier: NCT04550494 |
Recruitment Status :
Recruiting
First Posted : September 16, 2020
Last Update Posted : March 6, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 15, 2020 | ||||||
First Posted Date ICMJE | September 16, 2020 | ||||||
Last Update Posted Date | March 6, 2024 | ||||||
Actual Study Start Date ICMJE | April 26, 2021 | ||||||
Estimated Primary Completion Date | December 1, 2024 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Percent of patients who demonstrate simultaneous Rad51 activation [ Time Frame: At cycle 2 day 1 ] Will be measured as the percent of patients who demonstrate simultaneous Rad51 activation, defined to be at least 5% cells with at least 5 Rad51 foci, and lack of gamma-H2AX activation, defined to be less than 4% nuclear area positive (NAP), at the cycle 2 day 1 biopsy.
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Original Primary Outcome Measures ICMJE |
Percent of patients who demonstrate simultaneous Rad51 activation [ Time Frame: At cycle 2 day 1 ] Will be measured as the percent of patients who demonstrate simultaneous Rad51 activation, defined to be at least 5% cells with at least 5 Rad51 foci, and lack of gamma-H2AX activation, defined to be less than 4% nuclear area positive, at the cycle 2 day 1 biopsy.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Overall response rate [ Time Frame: Up to 30 days after last dose ] Will estimate the overall response rate (complete response + partial response) among eligible patients who have received at least one dose of talazoparib. A 95% confidence interval for this response rate will also be computed. For this analysis, response classifications will follow Response Evaluation Criteria in Solid Tumors version 1.1 guidelines.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
Tumor genomic alterations potentially associated with sensitivity or acquired resistance to talazoparib [ Time Frame: Up to 30 days after last dose ] Exploratory evaluations will be performed, with results reported with appropriate caveats about the exploratory nature of the analysis, and without formal adjustment for multiple comparisons.
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations | ||||||
Official Title ICMJE | A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response | ||||||
Brief Summary | This phase II trial studies if talazoparib works in patients with cancer that has spread to other places in the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors "one after the other" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes. | ||||||
Detailed Description | PRIMARY OBJECTIVE: I. Determine the pharmacodynamic (PD) effect of talazoparib in tumor biopsies for patients with aberrations in deoxyribonucleic acid (DNA) damage response genes who have or have not received prior PARP inhibitor treatment (separately). SECONDARY OBJECTIVE: I. Determine the response rate (complete response [CR] + partial response [PR]) of treatment with talazoparib in patients with aberrations in DNA damage response genes. EXPLORATORY OBJECTIVE: I. Investigate tumor genomic alterations potentially associated with sensitivity or acquired resistance to talazoparib. OUTLINE: Patients receive talazoparib orally (PO) once daily (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 computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the study. After completion of study treatment, patients are followed up at 30 days. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Treatment (talazoparib)
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.
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
36 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 1, 2024 | ||||||
Estimated Primary Completion Date | December 1, 2024 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | |||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04550494 | ||||||
Other Study ID Numbers ICMJE | NCI-2020-06906 NCI-2020-06906 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 000264 000246 10371 ( Other Identifier: National Cancer Institute LAO ) 10371 ( Other Identifier: CTEP ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | National Cancer Institute (NCI) | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | ||||||
Verification Date | February 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |