A Drug-drug Interaction Study Of Fluzoparib (SHR3162) on Patients With Recurrent Ovarian Cancer

NCT04718740 | Completed Phase 1

• 1 other identifier: FZPL-Ⅰ-120
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion

  DAY1,DAY 22

• Number of Participants With Treatment-Related Adverse Events

  through study completion, an average of 1 year

Study Arms (1)

fluzoparib

EXPERIMENTAL

* Experimental: group A Intervention: Drug: fluzoparib, caffeine, vitamin K, warfarin, omeprazole, and midazolam * Experimental: group B Intervention: Drug: fluzoparib, repaglinide and bupropion

Drug: fluzoparib

Interventions

fluzoparib DRUG

Group A: Caffeine, vitamin K, warfarin, omeprazole, and midazolam with or without fluzoparib Group B: Repaglinide and bupropion with or without fluzoparib

Also known as: caffeine, vitamin K, warfarin, omeprazole, midazolam, repaglinide and bupropion

fluzoparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• Subjects who do meet any of the following criteria will not be allowed to enter the study:
• Patients with previously (within 5 years) or at the same time with other incurable malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence for more than 5 years after radical operation
• months prior treatment with any poly adenosine diphosphate ribose polymerase inhibitor (PARPi)
• Patients with central nervous system metastasis
• Serous cavity effusion (including pleural effusion, ascites and pericardial effusion) with clinical symptoms and requiring symptomatic treatment; note: Patients with symptomatic serous cavity effusion can be included in the group if there is no disease, patients with symptomatic serous cavity effusion can be included in the group if they are treated with symptomatic treatment (anti-cancer drugs can not be used for serous cavity effusion treatment), and patients can be included in the group if judged by researchers

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

fluzoparib; Caffeine; Vitamin K; Warfarin; Omeprazole; Midazolam; repaglinide; Bupropion

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Polycyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Benzodiazepines; Benzazepines; Propiophenones; Ketones

Study Officials

• Jing Wang, Ph.D.

  Hunan Cancer Hospitol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: June 25, 2021
• Primary Completion: October 26, 2022
• Study Completion: July 15, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

CN (1)