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Ovarian CancerPhase 1/2NICHOLNCT06594679

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

A Phase 1/2 study testing Niraparib Tosylate Monohydrate in people with Ovarian Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Niraparib Tosylate Monohydrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteItaly
Study dates
26 Sep 2024to 18 Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Patients must have or agree to undergo tumor HRD testing and somatic BRCAmut status testing at screening.
  • Patients must agree to undergo blood samples during screening and at the end of treatment for cytogenetic analysis.
  • Phase 2 patients only: presence of measurable disease according to RECIST v1.1 criteria as assessed locally by Investigators.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.
  • Absolute neutrophil count (ANC) ≥ 1500/L (within 14 days of study drugs initiation).
  • Hemoglobin (Hgb) > 9 g/dL with no blood transfusion in the past 14 days (within 14 days of study drug[s] initiation).
  • Platelets > 100,000/L (within 14 days of study drug[s] initiation) with no platelets transfusion in the past 14 days.
  • Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if known hepatic metastases (within 14 days of study drugs initiation).
  • Serum bilirubin within normal limits (WNL) or ≤ 1.5 x ULN in patients with liver metastases; or total bilirubin ≤ 2.0 x ULN with direct bilirubin WNL in patients with well documented Gilbert's syndrome (within 14 days of study drugs initiation).
  • Patients should have calculated or measured creatinine clearance of ≥ 50 mL/min according to Cockroft-Gault.
  • Willingness and ability to comply with study and follow-up procedures.
  • Women of child-bearing potential must have a negative pregnancy test (serum) within 3 days prior to starting the study drug. Both males and females must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose; in this case, patients must take a monthly pregnancy test for the duration of the study. Female patients are considered to not be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 1 year without menses.
  • The methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include:
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  • oral;
  • intravaginal;
  • transdermal
  • progestogen-only hormonal contraception associated with inhibition of ovulation:
  • oral;
  • injectable;
  • implantable.
  • intrauterine device (IUD);
  • intrauterine hormone-releasing system (IUS);
  • bilateral tubal occlusion;
  • vasectomised partner;
  • sexual abstinence.
  • Additional inclusion criteria:
  • Patients must agree to not donate blood during the study or for 90 days after the last dose of study treatment.

Who cannot join

  • 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.
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  • 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.
  • Any known hypersensitivity or contraindication to the components of the study drugs.
  • Any of the following cardiac diseases currently or within the last 6 months: a. Unstable angina pectoris; b. Congestive heart failure; c. Acute myocardial infarction; d. Conduction abnormality not controlled with pacemaker or medication; e. Significant ventricular or supraventricular arrhythmias (patients with chronic rate- controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).
  • The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • Evidence of corrected QT interval (specifically QTc calculated using the Fridericia formula [QTcF]) > 470 msec from a single electrocardiogram (ECG) performed at study entry or congenital or acquired long QT syndrome.
  • The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • Pregnant or breast-feeding. Female patients should not breastfeed or store milk within 30 days of receiving the final dose of niraparib and abemaciclib.
  • Serious active infection at the time of study entry, or another serious underlying medical condition that would impair the ability of the patient to receive study treatment.
  • Presence of other active invasive cancers (except for definitively treated in-situ carcinomas [e.g. breast, cervix, bladder, skin melanoma], or basal or squamous cell carcinoma of the skin) within the past 24 months.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with protocol.
  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
  • History of human immunodeficiency virus (HIV) infection.
  • History Active HBV or HCV infection. Patients whose disease is controlled under antiviral therapy are eligible. Testing for HBV or HCV is not necessary unless clinically indicated.
  • History of cerebrovascular accident, PRES (posterior reversible encephalopathy syndrome), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.
  • Pregnant or breast-feeding. Female patients should not breastfeed or store milk during the study treatment and within 30 days of receiving the final dose of niraparib and abemaciclib.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Milano, 20133

    Francesco Raspagliesi, MD, +390223902719, francesco.rapagliesi@istitutotumori.mi.it

    Francesco Raspagliesi, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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

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.

Conditions
Ovarian Cancer
Being tested
Niraparib Tosylate Monohydrate
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Niraparib Tosylate MonohydrateDrug

    Also called Abemaciclib

    Combination of niraparib and abemaciclib

Study groups in NCT06594679
Study groupRoleWhat they receive
ARM 1ExperimentalNiraparib+Abemaciclib
Receives: Drug: Niraparib Tosylate Monohydrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dose finding

    This is a dose-escalation study of niraparib plus abemaciclib followed by an efficacy study for late-line treatment of ovarian cancer

    Measured: 18 months

  2. dose finding, phase Ib clinical trial

    Maximum tolerated dose (MTD) of niraparib in combination with abemaciclib in patients with advanced ovarian cancer defined as the dose level immediately below the dose at which ≥ 33% of patients experience dose-limiting toxicity as defined by protocol according to CTCAE 5.0

    Measured: From enrollment to the end of phase 1

  3. PART II: Disease control rate at 16 weeks (DCR16wks):

    proportion of patients whose disease shrinks (i.e. complete or partial response) or remains stable over 16 weeks after the start of niraparib + abemaciclib combination. Revised RECIST 1.1 criteria will be used to assess tumor response

    Measured: From enrollment of first patient of part II to to the 16-week-radiologic assessment of last patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start26 Sep 2024
  3. Primary completion20 Mar 2027 (estimated)
  4. Study completion18 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06594679
Sponsor's protocol ID
NICHOL INT 124/23
Acronym
NICHOL
Status last verified
Mar 2025
First submitted
19 Aug 2024
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Niraparib Tosylate Monohydrate in people with Ovarian Cancer, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dose finding (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06594679.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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