NCT05142241

Testing the Combination of Anti-Cancer Drugs Talazoparib and Temozolomide in Patients With Advanced Stage Rare Cancers, RARE 2 Trial

Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 2 Talazoparib and Temozolomide

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adrenal Gland Pheochromocytoma
• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm
• Paraganglioma

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT
DRUG	Talazoparib	Given PO
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2022-07-11
• Primary completion: 2025-09-26
• Completion: 2026-09-29
• First posted: 2021-12-02
• Last updated: 2025-11-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study