Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Intermittent PARPi Rucaparib Regimen: Rucaparib 1200 mg per day (600 mg BD,
12 hourly), twice a week regimen taken orally 72 hours apart (2400 mg per week).
Intervention2: Intermittent
Sponsors
Kolkata Gynecological Oncology Trials and Translational Research Group (KolGOTRG)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)- approved informed consent form prior to any study-specific evaluation. 2. Be greater than or equal to 18 years of age at the time the informed consent form is signed. 3. Have a histologically confirmed diagnosis of high-grade epithelial ovarian (serous or endometrioid histology), fallopian tube, or primary peritoneal cancer; for mixed histology, greater than 50 percent of the primary tumor must be confirmed to be high-grade serous or endometrioid upon re-review by local pathology. 4.Received prior platinum-based therapy and have platinum-sensitive disease meeting criteria for standard-of-care prescription for PARPi maintenance therapy, i.e., HRD or BRCA positive for frontline maintenance and HRD or BRCA platinum-sensitive 1st relapse greater than 6 months after completion of last platinum-based chemotherapy and showing response (SD or PR or CR) to platinum rechallenge. 5.Willing to provide tissues and blood sample for translational studies as per protocol. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7. Adequate organ function confirmed by the following laboratory values obtained within 14 days prior to the first dose of Rucaparib: a. Bone Marrow Function i. Absolute neutrophil count (ANC) greater than or equal to 1.5 times 10^9 per L ii. Platelets greater than 100 times 10^9 per L iii. Hemoglobin greater than or equal to 9 g/dL b. Hepatic Function i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 times upper limit of normal (ULN); if liver metastases, then less than or equal to 5 times ULN ii. Bilirubin less than or equal to 1.5 times ULN c. Renal Function i. Serum creatinine less than or equal to 1.5 times ULN or estimated glomerular filtration rate (GFR) greater than or equal to 45 mL per min using the Cockcroft Gault formula.
Exclusion criteria
Exclusion criteria: 1. History of a prior malignancy except curatively treated non-melanoma skin cancer, breast cancer treated curatively greater than 3 years ago, or other solid tumors treated curatively greater than 5 years ago, without evidence of recurrence 2. Prior treatment with any PARP inhibitor (oral or IV) except Iniparib less than 6 months prior to trial inclusion 3. Symptomatic and or untreated central nervous system (CNS) metastases. Patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks 4. Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption of rucaparib 5. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)- related illness, or history of chronic hepatitis B or C 6. Pregnant or breast feeding. Women of childbearing potential must have a negative serum pregnancy test less than 3 days prior to first dose of rucaparib. 7. Received treatment with, radiation, hormones, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs less than equals 14 days prior to first dose of rucaparib and or ongoing adverse effects from such treatment greater than NCI CTCAE Grade 1 8. Received administration of strong CYP1A2 or CYP3A4 inhibitors less than equals 7 days prior to first dose of rucaparib or have on-going requirements for these medications 9. Non-study related minor surgical procedure less than equals 5 days, or major surgical procedure less than equals 21 days, prior to first dose of rucaparib; in all cases, the patient must be sufficiently recovered and stable before treatment administration 10. Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 Months Progression Free Survival . Toxicity is a co-primary endpointTimepoint: 12 months PFS will be the primary efficacy endpoint in the recurrent setting and 24 months PFS for the frontline setting. Toxicity is a co-primary endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life,Time to symtoms and toxicity, financial toxicity,patient satisfaction, fear of cancer Progression,Biological response(Translational research)Timepoint: Secondary endpoints include 12/24-month QA-PFS, Time to symptoms or toxicity (TTST), QOL and MOST symptom trajectory, COST-PRO and cost-benefit analysis for financial tolerability, patient satisfaction, fear of progression and translational endpoints | — |
Countries
India
Contacts
Public ContactSayanti Mukherjee
KOLGOTRG
Outcome results
None listed