Recurrent Ovarian Cancer
Conditions
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 objective: To evaluate the safety of single dose of fluzoparib, caffeine, S-warfarin, omeprazole, midazolam, repaglinide and bupropion or fluzoparib in combination with caffeine, S-warfarin, omeprazole, midazolam, repaglinide and bupropion in patients with recurrent ovarian cancer.
Interventions
DRUGfluzoparib
Group A: Caffeine, vitamin K, warfarin, omeprazole, and midazolam with or without fluzoparib Group B: Repaglinide and bupropion with or without fluzoparib
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria to enter the study: 1. Patients are willing to participate this research and sign informed consent forms (ICFs) 2. Patients must be ≥ 18 years of age at the date of signing the informed consent; 3. 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%; 4. 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 5. ECOG Performance Status of 0-1 6. Patients must have a life expectancy of at least 3 months 7. 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； 8. 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 criteria
Inclusion Criteria: Subjects must meet all of the following criteria to enter the study: 1. Patients are willing to participate this research and sign informed consent forms (ICFs) 2. Patients must be ≥ 18 years of age at the date of signing the informed consent; 3. 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%; 4. 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 5. ECOG Performance Status of 0-1 6. Patients must have a life expectancy of at least 3 months 7. 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； 8. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion | DAY1, DAY22 | Peak Plasma Concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion | DAY1,DAY 22 | Half life (t1/2) |
| Number of Participants With Treatment-Related Adverse Events | through study completion, an average of 1 year | Safety: Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, adverse events (NCI-CTC AE 5.0), etc. |
Countries
China
Outcome results
None listed