Status:
COMPLETED
A Drug-drug Interaction Study Of Fluzoparib (SHR3162) on Patients With Recurrent Ovarian Cancer
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Recurrent Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary objective: To evaluate the pharmacokinetic effects of fluzoparib on caffeine, S-warfarin, omeprazole, midazolam, repaglinide and bupropion in patients with recurrent ovarian cancer. Secondary...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following criteria to enter the study:
- Patients are willing to participate this research and sign informed consent forms (ICFs)
- Patients must be ≥ 18 years of age at the date of signing the informed consent;
- Patients with histologically diagnosed relapsed high grade (or middle and low differentiation) serous ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by pathology; ovarian endometrioid adenocarcinoma ≥ grade II; mixed type tumor: high grade serous type or endometrioid component ≥ grade II should be more than 50%;
- Patients with platinum sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer achieved complete or partial remission after platinum containing chemotherapy (carboplatin and cisplatin only). Platinum sensitive defined as having disease progression greater than 6 months after completion of their last dose of platinum chemotherapy. Patient must have received, at least 4 cycles of a platinum based chemotherapy regimen for the last chemotherapy course
- ECOG Performance Status of 0-1
- Patients must have a life expectancy of at least 3 months
- Patients must have normal organ and bone marrow function measured prior to administration of study treatment as defined below:
- HB≥100g/L； ANC≥1.5×109/L； PLT≥100×109/L or 1x UN TBIL≤1.5×ULN； ALT和AST≤3×ULN； Cr≤1.5×ULN； Albumin\>30g/L；
- Agree to abstain from sex or use effective non-drug contraceptives from screening to at least 6 months after the last study drug administration (female subjects are also required to abstain or use effective non-drug contraceptives two weeks prior to study entry)
Exclusion
- Inclusion Criteria:
- Subjects must meet all of the following criteria to enter the study:
- Patients are willing to participate this research and sign informed consent forms (ICFs)
- Patients must be ≥ 18 years of age at the date of signing the informed consent;
- Patients with histologically diagnosed relapsed high grade (or middle and low differentiation) serous ovarian cancer, fallopian tube cancer or primary peritoneal cancer confirmed by pathology; ovarian endometrioid adenocarcinoma ≥ grade II; mixed type tumor: high grade serous type or endometrioid component ≥ grade II should be more than 50%;
- Patients with platinum sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer achieved complete or partial remission after platinum containing chemotherapy (carboplatin and cisplatin only). Platinum sensitive defined as having disease progression greater than 6 months after completion of their last dose of platinum chemotherapy. Patient must have received, at least 4 cycles of a platinum based chemotherapy regimen for the last chemotherapy course
- ECOG Performance Status of 0-1
- Patients must have a life expectancy of at least 3 months
- Patients must have normal organ and bone marrow function measured prior to administration of study treatment as defined below:
- HB≥100g/L； ANC≥1.5×109/L； PLT≥100×109/L or 1x UN TBIL≤1.5×ULN； ALT和AST≤3×ULN； Cr≤1.5×ULN； Albumin\>30g/L；
- Agree to abstain from sex or use effective non-drug contraceptives from screening to at least 6 months after the last study drug administration (female subjects are also required to abstain or use effective non-drug contraceptives two weeks prior to study entry)
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04718740
Start Date
June 25 2021
End Date
July 15 2023
Last Update
August 14 2023
Active Locations (1)
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1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013