NCT05142241

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

Active, enrolled Phase 2 Last updated 18 November 2025

What this trial tests

Phase 2 trial testing Biopsy Procedure in Adrenal Gland Pheochromocytoma in 14 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

11 July 2022

Primary endpoint
26 September 2025

29 September 2026

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	11 July 2022
Primary completion	26 September 2025
Estimated completion	29 September 2026
Sites	2 locations across United States

Drugs / interventions tested

• Biopsy Procedure
• Biospecimen Collection — full drug profile →
• Computed Tomography
• Talazoparib (talazoparib) — full drug profile →
• Temozolomide (temozolomide) — full drug profile →

Conditions studied

• Adrenal Gland Pheochromocytoma — all drugs for Adrenal Gland Pheochromocytoma →
• Hematopoietic and Lymphatic System Neoplasm — all drugs for Hematopoietic and Lymphatic System Neoplasm →
• Malignant Solid Neoplasm — all drugs for Malignant Solid Neoplasm →
• Paraganglioma — all drugs for Paraganglioma →

Sponsor

National Cancer Institute (NCI)

Who can join

12 and older, any sex, with Adrenal Gland Pheochromocytoma or Hematopoietic and Lymphatic System Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted Therapies in Pheochromocytoma and Paraganglioma.
   Wang K, Crona J, Beuschlein F, Grossman AB, et al · · 2022 · cited 45× · PMID 35973976 · DOI 10.1210/clinem/dgac471
2. Multicellular Complex Tumor Spheroid Response to DNA Repair Inhibitors in Combination with DNA-damaging Drugs.
   Dexheimer TS, Coussens NP, Silvers T, Wright J, et al · · 2023 · cited 15× · PMID 37637936 · DOI 10.1158/2767-9764.crc-23-0193
3. Pheochromocytoma: a changing perspective and current concepts.
   Kiriakopoulos A, Giannakis P, Menenakos E. · · 2023 · cited 12× · PMID 37916027 · DOI 10.1177/20420188231207544
4. Therapy Resistant Gastroenteropancreatic Neuroendocrine Tumors.
   McClellan K, Chen EY, Kardosh A, Lopez CD, et al · · 2022 · cited 12× · PMID 36230691 · DOI 10.3390/cancers14194769
5. Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
   Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y
6. Molecular Genetics of Pheochromocytoma/Paraganglioma.
   Wachtel H, Nathanson KL. · · 2024 · cited 3× · PMID 39328362 · DOI 10.1016/j.coemr.2024.100527