Actively Recruiting
A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-03-28
73
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has read and signed informed consent
- Female aged over 18 years
- Life expectancy of at least 3 months
- Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Confirmed recurrent cancer with no curative treatment available
- Able to provide archived tumor tissue or undergo biopsy if needed
- Completed at least 2 prior chemotherapy regimens for platinum-sensitive disease
- Last therapy completed more than 4 weeks prior with confirmed disease progression
- May have received maintenance therapy with a PARP inhibitor but remain platinum sensitive or showed progression on PARP inhibitor
- Agree to tumor HRD and somatic BRCAmut testing at screening
- Agree to blood sample collection during screening and treatment
- Phase 2 patients must have measurable disease by RECIST v1.1
- ECOG performance status of 0 or 1
- Absolute neutrophil count ≥ 1500/L within 14 days before treatment
- Hemoglobin > 9 g/dL with no recent transfusion
- Platelets > 100,000/L with no recent transfusion
- Liver enzymes and bilirubin within specified limits
- Creatinine clearance ≥ 50 mL/min
- Willingness and ability to comply with study procedures
- Negative pregnancy test within 3 days before starting treatment
- Use of effective birth control during study and for 6 months after last dose
- Agree not to donate blood during study and for 90 days after last dose
You will not qualify if you...
- Prior immunologic therapy within 4 weeks before first dose
- Major surgery within 28 days or minor surgery within 7 days before treatment
- Recent radiotherapy without full recovery and 14-day washout
- History of severe hematological toxicity lasting more than 4 weeks
- Uncontrolled hypertension
- Significant toxicity from prior therapy that prevents new treatment
- Inability to swallow oral medications or gastrointestinal disorders affecting absorption
- Central nervous system disease except stable treated brain metastases
- Use of certain drugs affecting CYP3A4 that cannot be stopped
- Use of prohibited herbal medications within 7 days before treatment
- Known allergy or contraindication to study drugs
- Recent or serious cardiac diseases or arrhythmias
- History of syncope, ventricular arrhythmia, or sudden cardiac arrest
- QTc interval > 470 msec or long QT syndrome
- Serious uncontrolled medical conditions
- Pregnant or breastfeeding
- Serious infection or other medical condition impairing treatment
- Other active invasive cancers within past 24 months except certain treated carcinomas
- Psychological or social conditions preventing study compliance
- Myelodysplastic syndrome or acute myeloid leukemia
- Previous allogenic bone marrow or double umbilical cord blood transplant
- History of HIV infection
- Active hepatitis B or C infection unless controlled
- Recent cerebrovascular accident, PRES, pulmonary embolism, or untreated deep vein thrombosis
- Recent experimental treatment within 30 days or 5 half-lives
- Pregnant or breastfeeding females prohibited from participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano, Italy, 20133
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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