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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluzoparib | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluzoparib | Drug | Group A: Caffeine, vitamin K, warfarin, omeprazole, and midazolam with or without fluzoparib Group B: Repaglinide and bupropion with or without fluzoparib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion | Peak Plasma Concentration (Cmax) | DAY1, DAY22 |
| Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion | Area under the plasma concentration versus time curve (AUC) | DAY1, DAY22 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion | Half life (t1/2) | DAY1,DAY 22 |
| Number of Participants With Treatment-Related Adverse Events |
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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)
Exclusion Criteria:
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)
Exclusion Criteria:
Subjects who do meet any of the following criteria will not be allowed to enter the study:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Wang, Ph.D. | Hunan Cancer Hospitol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| D002110 | Caffeine |
| D014812 | Vitamin K |
| D014859 | Warfarin |
| D009853 | Omeprazole |
| D008874 | Midazolam |
| C072379 | repaglinide |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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|
Safety: Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, adverse events (NCI-CTC AE 5.0), etc.
| through study completion, an average of 1 year |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D011427 | Propiophenones |
| D007659 | Ketones |