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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Sep 29, 2026 to Sep 23, 2027
    • Eligibility criteria expanded, about 27 words
  2. Re-verified, no change to tracked fieldsv41
  3. Results first posted: Aug 12, 2026v40
  4. Primary endpoint revisedv39
  5. Re-verified, no change to tracked fieldsv38
Show 36 earlier versionsHide 36 earlier versions
  1. Trial status: Suspended to Active, Not Recruiting
    • Study completion date: Sep 26, 2026 to Sep 29, 2026
    v37
  2. Enrollment target: estimated 34 to confirmed 14
    • Primary completion date changed from estimate of Apr 15, 2026 to Sep 26, 2025
    • Study completion date: Apr 15, 2026 to Sep 26, 2026
    v36
  3. 3 versions Re-verified since Jul 15, 2025, no change to tracked fieldsv33-v35
  4. Interventions: Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Talazoparib (Drug), Temozolomide (Drug) to Biopsy Procedure (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Talazoparib (Drug), Temozolomide (Drug)v32
  5. 3 versions Re-verified since Oct 22, 2024, no change to tracked fieldsv29-v31
  6. Trial status: Recruiting to Suspended Sponsor's reason: Other - Pending an amendment to add more patient cohorts.
    • Site details revised at 2 of 2 sites
    v28
  7. 6 versions Re-verified since Oct 20, 2023, no change to tracked fieldsv22-v27
  8. Interventions: Computed Tomography (Procedure), Talazoparib (Drug), Temozolomide (Drug) to Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Talazoparib (Drug), Temozolomide (Drug)
    • Eligibility criteria expanded, about 10 words
    • Study description shortened, about 17 words
    • Study title shortened, about 4 words
    v21
  9. Start date: Mar 23, 2022 to Jul 11, 2022v20
  10. 4 versions Re-verified since Jan 3, 2023, no change to tracked fieldsv16-v19
  11. Study sites: 3 to 2v15
  12. Study sites: 2 to 3v14
  13. Re-verified, no change to tracked fieldsv13
  14. Interventions: Talazoparib (Drug), Temozolomide (Drug) to Computed Tomography (Procedure), Talazoparib (Drug), Temozolomide (Drug)
    • Eligibility criteria expanded, about 65 words
    • Study description expanded, about 36 words
    v12
  15. 3 versions Re-verified since May 4, 2022, no change to tracked fieldsv9-v11
  16. Study sites: 1 to 2v8
  17. Re-verified, no change to tracked fieldsv7
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 15, 2022 to Mar 23, 2022
    • Eligibility criteria shortened, about 115 words
    v6
  19. Primary and study completion dates: Jan 1, 2025 to Apr 15, 2026v5
  20. Start date: Jan 14, 2022 to Apr 15, 2022v4
  21. Study description expanded, about 25 wordsv3
  22. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05142241
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Malignant Solid Neoplasm
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov