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A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL) | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer: a Single Center, Open Label, Single Arm, Phase Ib/II Trial NICHOL TRIAL

NCT06594679•Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Has read and understands the informed consent form and has given written informed consent prior to any study procedures.
•Age \> 18 years
•Life expectancy of at least 3 months
•Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer
•Confirmed recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer for which there is no known or established treatment available with curative intent.
•Able to provide archived tumor tissue;(formalin fixed-paraffin embedded (FFPE) tumor sample or a minimum of 20 unstained slides is required for study eligibility.
•NOTE: if archived tissue is not available, patient must be willing to undergo a tumor biopsy at screening if medically feasible.
•Patients must have completed at least 2 previous chemotherapy regimens for platinum sensitive disease (\> 6 months). Patients must have completed their last therapy regimen \> 4 weeks prior to treatment initiation and have radiological confirm of progression disease.
•Patients could have received maintenance therapy with a PARPi, but they must remain sensitive to platinum-based chemotherapy, based on the radiological or CA-125 response to their most recent course of platinum-based chemotherapy (carboplatin, cisplatin or oxaliplatin) or have demonstrated progressive disease while taking a PARP inhibitor as a previous therapy. Response to prior PARP inhibitor is not required.
•Prior PARP therapy could have been administered as either treatment for recurrent disease or as maintenance following prior treatment.
+27 more criteria

Exclusion Criteria

•Any other prior therapy directed at the malignant tumor, including immunologic agents administered within 4 weeks prior to first dose of study drug
•Major surgical procedures ≤ 28 days of beginning study treatment, or minor surgical procedures \< 7 days. No timeline window required for port-a-cath placement.
•Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
•History of any ≥ grade 3 hematological toxicity due to prior chemotherapy that persisted for more than 4 weeks.
•Patient has uncontrolled hypertension according to CTCAE v. 5.0
•Grade \> 1 toxicity from prior therapy (except alopecia or anorexia) that contraindicates start of new treatment.
•Patient has inability to swallow oral medications or patients with gastrointestinal disorders likely to interfere with absorption of the study medication. Note: Patient may not have a percutaneous endoscopic gastrostomy (PEG) tube or be receiving total parenteral nutrition (TPN).
•Known central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or hemorrhage for at least 28 days after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of brain metastases for at least 14 days prior to enrollment.
•Chronic assumption of drugs or other products with a narrow therapeutic index and known to be CYP3A4 substrates, or drugs or other products known to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued 2 weeks prior to day -3 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. Co-administration of aprepitant or fosaprepitant during this study is prohibited.
•Herbal preparations are not allowed throughout the study. These herbal medications include but are not limited to: St. John's wort, kava, ephedra (mahung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng, grapefruit and seville orange. Patients should stop using these herbal medications at least 7 days prior to first dose of study treatment.
+16 more criteria

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milano, Italy

Key Dates

Start Date

September 26, 2024

Primary Completion Date

March 20, 2027

Completion Date

September 18, 2027

Last Updated

March 28, 2025

Enrollment

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

Niraparib Tosylate Monohydrate

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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