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NCT04019327
A Study of the Drugs Talazoparib and Temozolomide in Prostate Cancer
Phase 1, PHASE2 trial testing Talazoparib in Prostate Cancer in 16 participants. Completed in 4 December 2025.
4 December 2025
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 11 July 2019 |
| Primary completion | 4 December 2025 |
| Estimated completion | 4 December 2025 |
| Sites | 9 locations across United States |
Drugs / interventions tested
- Talazoparib (talazoparib) — full drug profile →
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →
- Prostate Neoplasm — all drugs for Prostate Neoplasm →
- Prostate Cancer Metastatic — all drugs for Prostate Cancer Metastatic →
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):
-
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 -
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 -
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 -
PARP Inhibitors in Metastatic Prostate Cancer: Evidence to Date.
Nizialek E, Antonarakis ES. · · 2020 · cited 58× · PMID 32982407 · DOI 10.2147/cmar.s227033 -
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 -
PARP inhibitor combinations in prostate cancer.
Pezaro C. · · 2020 · cited 28× · PMID 32215055 · DOI 10.1177/1758835919897537 -
Targeting treatment options for castration-resistant prostate cancer.
Miller DR, Ingersoll MA, Teply BA, Lin MF. · · 2021 · cited 20× · PMID 33816699 -
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:
- PubMed search for NCT04019327
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06218628 — Pacritinib w/ Talazoparib in Pts w/ Myeloproliferative Neoplasms Unresponsive to JAK2 Inhibition · Phase 1 · recruiting
- NCT05071937 — ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer · Phase 2 · recruiting
- NCT05327010 — Testing the Combination of the Anti-cancer Drugs ZEN003694 (ZEN-3694) and Talazoparib in Patients With Advanced Solid Tu · Phase 2 · recruiting
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
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- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other Memorial Sloan Kettering Cancer Center trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04019327 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 15 December 2025
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.
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