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NCT04019327

A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer

Completed Phase 1, PHASE2 Last updated 15 December 2025
What this trial tests

Phase 1, PHASE2 trial testing Talazoparib in Prostate Cancer in 16 participants. Completed in 4 December 2025.

Timeline
11 July 2019
Primary endpoint
4 December 2025
4 December 2025

Quick facts

Lead sponsorMemorial Sloan Kettering Cancer Center
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment16
Start date11 July 2019
Primary completion4 December 2025
Estimated completion4 December 2025
Sites9 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, male only, with Prostate Cancer or Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine what the safest dose of talazoparib plus temozolomide for participants with metastatic castration resistant prostate cancer. The purpose of Phase II is to test the efficacy (effectiveness) of talazoparib and temozolomide at the maximum tolerated dose, which was determined to be 1mg talazoparib and 75mg/m² temozolomide in the Phase Ib portion of this study.

Publications & conference data

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

  1. DNA Damage Response in Cancer Therapy and Resistance: Challenges and Opportunities.
    Jurkovicova D, Neophytou CM, Gašparović AČ, Gonçalves AC. · · 2022 · cited 95× · PMID 36499000 · DOI 10.3390/ijms232314672
  2. BRCA Mutations in Prostate Cancer: Prognostic and Predictive Implications.
    Messina C, Cattrini C, Soldato D, Vallome G, et al · · 2020 · cited 87× · PMID 32963528 · DOI 10.1155/2020/4986365
  3. Genetic aberrations in DNA repair pathways: a cornerstone of precision oncology in prostate cancer.
    Lozano R, Castro E, Aragón IM, Cendón Y, et al · · 2021 · cited 81× · PMID 33106584 · DOI 10.1038/s41416-020-01114-x
  4. PARP Inhibitors in Metastatic Prostate Cancer: Evidence to Date.
    Nizialek E, Antonarakis ES. · · 2020 · cited 58× · PMID 32982407 · DOI 10.2147/cmar.s227033
  5. PARP inhibitors in metastatic prostate cancer.
    Taylor AK, Kosoff D, Emamekhoo H, Lang JM, et al · · 2023 · cited 50× · PMID 37168382 · DOI 10.3389/fonc.2023.1159557
  6. PARP inhibitor combinations in prostate cancer.
    Pezaro C. · · 2020 · cited 28× · PMID 32215055 · DOI 10.1177/1758835919897537
  7. Targeting treatment options for castration-resistant prostate cancer.
    Miller DR, Ingersoll MA, Teply BA, Lin MF. · · 2021 · cited 20× · PMID 33816699
  8. Androgen Receptor Signaling Inhibition in Advanced Castration Resistance Prostate Cancer: What Is Expected for the Near Future?
    Pozas J, Álvarez Rodríguez S, Fernández VA, Burgos J, et al · · 2022 · cited 16× · PMID 36551557 · DOI 10.3390/cancers14246071

Verify or expand the search:

Other trials of Talazoparib

Trials testing the same drug.

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04019327.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing