Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients With Advanced Stage Rare Cancers, RARE 2 Trial
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ClinicalTrials.gov Identifier: NCT05142241 |
Recruitment Status :
Recruiting
First Posted : December 2, 2021
Last Update Posted : April 22, 2024
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Tracking Information | |||||||
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First Submitted Date ICMJE | December 1, 2021 | ||||||
First Posted Date ICMJE | December 2, 2021 | ||||||
Last Update Posted Date | April 22, 2024 | ||||||
Actual Study Start Date ICMJE | July 11, 2022 | ||||||
Estimated Primary Completion Date | April 15, 2026 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Objective response [ Time Frame: Up to 9 months from study enrollment ] Defined as a complete or partial response by Response Evaluation Criteria in Solid Tumors version 1.1 criteria. A Simon two-stage design (between minimax and optimal) will be employed.
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Original Primary Outcome Measures ICMJE |
Objective response [ Time Frame: Up to 9 months ] Defined as a complete or partial response by Response Evaluation Criteria in Solid Tumors version 1.1 criteria. A Simon two-stage design (between minimax and optimal) will be employed.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||
Brief Title ICMJE | Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients With Advanced Stage Rare Cancers, RARE 2 Trial | ||||||
Official Title ICMJE | Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 2 Talazoparib and Temozolomide | ||||||
Brief Summary | This phase II trial tests whether combination of talazoparib and temozolomide works to shrink tumors in patients with rare cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Talazoparib is an inhibitor of poly adenosine diphosphate-ribose polymerase (PARP), an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It damages the cell's DNA and may kill cancer cells. Giving talazoparib in combination with temozolomide may help shrink advanced rare cancers or stop them from growing. | ||||||
Detailed Description | PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with advanced rare cancers who have objective responses (OR) to treatment with temozolomide and talazoparib. EXPLORATORY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months on study agents. II. To identify genomic and transcriptomic determinants of response and resistance in tumor biopsy specimens. III. To examine genomic alterations in circulating tumor deoxyribonucleic acid (DNA) (ctDNA) and circulating tumor cells (CTCs) that may be associated with response or resistance. IV. To evaluate the pharmacodynamic effects of the combination on biomarkers of cell death and epithelial-to-mesenchymal transition in tumor tissue and CTCs. OUTLINE: Patients receive talazoparib orally (PO) once daily (QD) on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and may optionally undergo biopsy and/or blood sample collection at baseline and on the trial. After completion of study treatment, patients are followed up for 30 days or until one of the following occurs: patient enrolls on another protocol, patient receives standard of care, or death, whichever comes first. |
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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, temozolomide)
Patients receive talazoparib PO QD on days 1-28 and temozolomide PO QD on days 2-6 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scans and may optionally undergo biopsy and/or blood sample collection at baseline and on the trial.
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 |
34 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | April 15, 2026 | ||||||
Estimated Primary Completion Date | April 15, 2026 (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 | 12 Years and older (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | |||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT05142241 | ||||||
Other Study ID Numbers ICMJE | NCI-2021-12858 NCI-2021-12858 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 000692 10490 ( Other Identifier: National Cancer Institute LAO ) 10490 ( 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 | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |