NCT06594679 (NICHOL) is a Phase 1, PHASE2 clinical trial of Niraparib Tosylate Monohydrate in Ovarian Cancer, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

Who is sponsoring NCT06594679?

NCT06594679 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

What drugs are being tested in NCT06594679?

Interventions in NCT06594679: Niraparib Tosylate Monohydrate.

What condition does NCT06594679 study?

NCT06594679 studies Ovarian Cancer.

Is NCT06594679 still recruiting?

NCT06594679 is currently recruiting now. Last updated 28 March 2025.

Last reviewed 2025-03-28 · How we verify

NCT06594679: NICHOL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1, PHASE2 Last updated 28 March 2025

What this trial tests

Phase 1, PHASE2 trial testing Niraparib Tosylate Monohydrate in Ovarian Cancer in 73 participants. Currently enrolling.

Timeline

26 September 2024

Primary endpoint
20 March 2027

18 September 2027

Quick facts

Lead sponsor	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	73
Start date	26 September 2024
Primary completion	20 March 2027
Estimated completion	18 September 2027
Sites	1 location across Italy

Drugs / interventions tested

Niraparib Tosylate Monohydrate — full drug profile →

Conditions studied

Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an interventional trial. The goal of this clinical trial is dose finding. There are two phases: phase Ib to determine the MTD and recommended phase II dose of niraparib in combination with abemaciclib in patients with advanced ovarian cancer. Target population will be patients (woman, age \> 18 years) with epithelial ovarian, fallopian tube or peritoneal cancer treated with at least 2 lines of therapy.

Publications & conference data

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

Research progress of DNA damage repair (DDR) and DDR inhibitors in tumor immunotherapy.
Liu Q, Zhang C, Gao Y, Feng D, et al · · 2025 · PMID 41402978 · DOI 10.1186/s12957-025-04101-9
Antitumor activity and structure-activity relationship of poly (ADP-ribose) polymerase (PARP)-based dual inhibitors.
Yang C, Shang Y, Li X, Li J, et al · · 2026 · PMID 41395847 · DOI 10.1080/14756366.2025.2598478

Verify or expand the search:

Other trials of Niraparib Tosylate Monohydrate

Trials testing the same drug.

NCT05174455 — Niraparib for the Treatment of Leiomyosarcoma · Phase 2 · withdrawn
NCT04481113 — Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer · Phase 1 · completed

Other recruiting trials for Ovarian Cancer

Currently open trials in the same condition.

NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Fondazione IRCCS Istituto Nazionale dei Tumori, Milano trials

Trials by the same sponsor.

NCT06799624 — Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr · not yet recruiting
NCT07253402 — Microbiota-guided Radiotherapy for Head and Neck Cancer · recruiting
NCT06938724 — Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer · Phase 2 · recruiting
NCT06999824 — Revisiting the Concept of Nerve Sparing Radical Hysterectomy · not yet recruiting
NCT06986486 — Liver Transplantation for Unresectable Perihilar Cholangiocarcinoma · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06594679 (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 Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Last refreshed: 28 March 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/NCT06594679.

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