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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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• 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.

• 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.

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2027-09-18
Participants
Target number of participants: 73
Treatments
Experimental: ARM 1
Niraparib+Abemaciclib
Related Therapeutic Areas
Sponsors
Collaborators: Eli Lilly and Company, GlaxoSmithKline
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov