A Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL)
NCT06594679 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2025-03-28
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.
Conditions
Interventions
- DRUG
-
Niraparib Tosylate Monohydrate
Combination of niraparib and abemaciclib
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-26
- Primary Completion
- 2027-03-20
- Completion
- 2027-09-18
- FDA Drug
- Yes
Countries
- Italy
Study Locations
More Related Trials
-
Phase Ib/IIa Trial to Evaluate Oregovomab and Nivolumab in Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
NCT03100006 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Niraparib Maintenance in HRD-Positive Advanced Ovarian Cancer Following Front-Line Chemotherapy + Bevacizumab
NCT06141265 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
NCT03326193 ·Status: COMPLETED ·Phase: PHASE2
-
Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment
NCT04679064 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer
NCT03574779 ·Status: COMPLETED ·Phase: PHASE2
-
Niraparib Versus Bevacizumab as Maintenance Therapy in Patients With de Novo Ovarian Cancer Without Homologous Recombination Deficiency
NCT06827353 ·Status: RECRUITING
-
A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy
NCT05460000 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian Cancer
NCT03895788 ·Status: UNKNOWN ·Phase: PHASE1
-
Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer
NCT03759587 ·Status: COMPLETED ·Phase: PHASE2
-
An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
NCT05887609 ·Status: RECRUITING ·Phase: PHASE2
-
Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study
NCT04617470 ·Status: UNKNOWN
-
NIRAPK : Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment for Ovarian Cancer Patients.
NCT04861181 ·Status: TERMINATED ·Phase: PHASE4
-
A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
NCT03695380 ·Status: COMPLETED ·Phase: PHASE1
-
Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
NCT05009082 ·Status: RECRUITING ·Phase: PHASE3
-
Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin
NCT04620954 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
The Real World Efficacy and Safety of Niraparib in Korean Women With Primary and Recurrent Epithelial Ovarian Cancer
NCT06086665 ·Status: COMPLETED
-
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
NCT06580314 ·Status: RECRUITING ·Phase: PHASE3
-
Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study
NCT04091204 ·Status: UNKNOWN ·Phase: PHASE2
-
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
NCT06121401 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
NCT04633239 ·Status: RECRUITING ·Phase: PHASE1
-
Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer
NCT05183984 ·Status: RECRUITING ·Phase: PHASE2
-
Efficacy and Adverse Effects of Niraparib in Ovarian Cancer.
NCT05583799 ·Status: UNKNOWN
-
Phase II ABT-888 With Cyclophosphamide
NCT01306032 ·Status: COMPLETED ·Phase: PHASE2
-
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
NCT04469764 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Niraparib in Patients With Relapsed Ovarian Cancer
NCT04392102 ·Status: COMPLETED ·Phase: PHASE2