Niraparib Tosylate Monohydrate

DRUG4 trials

Sponsors

University of California, Davis, OHSU Knight Cancer Institute, David Liebner, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Conditions

ATM Gene MutationAnatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8

Phase 1

Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer

CompletedNCT04481113

OHSU Knight Cancer InstituteAnatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8 +17

Start: 2021-06-07End: 2025-06-20Updated: 2026-01-29

A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)

RecruitingNCT06594679

Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoOvarian Cancer

Start: 2024-09-26End: 2027-09-18Target: 73Updated: 2025-03-28

Phase 2

Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects

TerminatedNCT04030559

University of California, DavisATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation +14

Start: 2020-02-25End: 2025-11-07Updated: 2026-05-14

Niraparib for the Treatment of Leiomyosarcoma

WithdrawnNCT05174455

David Liebner, MDLocally Advanced Leiomyosarcoma, Metastatic Leiomyosarcoma, Stage IIIA Retroperitoneal Sarcoma AJCC v8 +4

Start: 2023-12-01End: 2025-12-31Updated: 2023-09-18

Related Papers

Neoadjuvant niraparib in men with DNA repair gene deficient clinically localized prostate cancer: Clinical and molecular results from a phase 2 investigator-initiated trial.

Journal of Clinical Oncology2025-05-281 citations

A phase 1 study of abemaciclib and niraparib as neoadjuvant therapy in hormone receptor positive and HER2 negative breast cancer.

Journal of Clinical Oncology2025-05-28

Neoadjuvant fuzuloparib combined with abiraterone for localized high-risk prostate cancer (FAST-PC): A single-arm phase 2 study.

2025-03-074 citations

Neo-adjuvant PARP inhibition prior to prostatectomy: A phase II biomarker-driven trial for men with high-risk, localized prostate cancer and alterations in DNA repair genes.

Journal of Clinical Oncology2023-02-205 citations