Recurrent Ovarian CancerPhase 1NCT04718740
A Drug-drug Interaction Study Of Fluzoparib (SHR3162) on Patients With Recurrent Ovarian Cancer
A Phase 1 study testing fluzoparib in people with Recurrent Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Ovarian Cancer
- What is being tested?
- fluzoparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2021to 15 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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 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)
Who cannot join
- 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
- 3 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
- Pre-existing duodenal stent, recent or existing bowel obstruction, and/or any gastrointestinal disorder or defect that would interfere with absorption of study drugs
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- There are clinical cardiac symptoms or diseases that can not be well controlled, such as: (1) NYHA grade 2 or above cardiac insufficiency, (2) unstable angina pectoris, (3) acute myocardial infarction within one year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc > 470ms
- Patients with abnormal coagulation function (INR > 1.5 or PT > ULN + 4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant therapy
- Contraindications of midazolam (allergic to benzodiazepine, myasthenia gravis, schizophrenia, severe depression patients)
- Warfarin contraindications (liver and kidney dysfunction, severe hypertension, coagulation dysfunction with bleeding tendency, active ulcer, trauma, threatened abortion, recent surgery)
- Patients with contraindications to repaglinide and bupropion (patients with type I diabetes, including insulin-dependent IDDM and C-peptide negative diabetes, diabetic ketoacidosis with or without coma, patients with anorexia nervosa or bulimia, patients with a history of severe epilepsy; patients with sudden abstinence or withdrawal of sedatives); patients with diabetes other than the above Abnormal control
- Not recovered from the previous adverse events before the first medication (previous treatment adverse events, excluding hair loss and fatigue, recovered to ≤ 1 level)
- Other clinical trial drugs were taken within 4 weeks before the first medication;
- CYP1A2, CYP3A4, CYP2C9, CYP2C19 inducers or CYP1A2, CYP3A4, CYP2C9 and CYP2C19 inhibitors or P-gp inhibitors were taken within 4 weeks before the first medication (for group A); CYP3A4, cyp2c8 and CYP2B6 inducers were taken within 4 weeks before the first medication or CYP3A4, cyp2c8 and CYP2B6 inhibitors or transporter OATP1B1 were taken within 2 weeks (or 5 half lives)/ P-gp inhibitor (for group B)
- Prior treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs within 14 days prior to day 1
- Alcoholics within 3 months before the first medication (drinking 14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits, or 100 ml of wine), and smokers within 3 months before the first medication (smoking ≥ 5 cigarettes per day);
- Ingestion of grapefruit or grapefruit products within 7 days before the first medication, or ingestion of food or drink containing caffeine, xanthine or alcohol within 72 hours before the first medication; strenuous exercise within 4 days before the first medication; or other factors affecting drug absorption, distribution, metabolism and excretion
- Patients with history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation
- Syphilis infection or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU / ml; hepatitis C reference: HCV antibody positive and HCV copy number > upper limit of normal value)
- Patients with active infections requiring antimicrobial therapy (e.g. antibiotics, antiviral drugs, antifungal drugs);
- According to the judgment of the researchers, there are concomitant diseases (serious diabetes, thyroid diseases, etc.) that seriously endanger the safety of patients or affect the completion of the study
- Patients with history of drug allergy, or allergic to apatinib or ingredients
- The researcher judges other situations that may affect the clinical research and the judgment of research results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Multi-center Study to Determine the Effect of Fluzoparib on Pharmacokinetics of Caffeine, S-Warfarin, Omeprazole, Midazolam, Repaglinide and Bupropion in Patients With Recurrent Ovarian Cancer
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
- Being tested
- fluzoparib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluzoparibDrug
Also called caffeine, vitamin K, warfarin, omeprazole, midazolam, repaglinide and bupropion
Group A: Caffeine, vitamin K, warfarin, omeprazole, and midazolam with or without fluzoparib Group B: Repaglinide and bupropion with or without fluzoparib
| Study group | Role | What they receive |
|---|---|---|
| fluzoparib | Experimental | * Experimental: group A Intervention: Drug: fluzoparib, caffeine, vitamin K, warfarin, omeprazole, and midazolam
* Experimental: group B Intervention: Drug: fluzoparib, repaglinide and bupropion Receives: Drug: fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion
Peak Plasma Concentration (Cmax)
Measured: DAY1, DAY22
Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion
Area under the plasma concentration versus time curve (AUC)
Measured: DAY1, DAY22
Secondary outcomes (2)
Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion
Half life (t1/2)
Measured: DAY1,DAY 22
Number of Participants With Treatment-Related Adverse Events
Safety: Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, adverse events (NCI-CTC AE 5.0), etc.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Jun 2021
- Primary completion26 Oct 2022
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Wang, Ph.D., Principal investigator, Hunan Cancer Hospitol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718740
- Sponsor's protocol ID
- FZPL-Ⅰ-120
- Status last verified
- Aug 2023
- First submitted
- 14 Jan 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-center Study to Determine the Effect of Fluzoparib on Pharmacokinetics of Caffeine, S-Warfarin, Omeprazole, Midazolam, Repaglinide and Bupropion in Patients With Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04718740
- Acronym / sponsor ID
- FZPL-Ⅰ-120
- Conditions
- Recurrent Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluzoparib | Experimental | Drug: fluzoparib* Experimental: group A Intervention: Drug: fluzoparib, caffeine, vitamin K, warfarin, omeprazole, and midazolam * Experimental: group B Intervention: Drug: fluzoparib, repaglinide and bupropion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (23 listed)
- 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
- 3 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluzoparibAlso: caffeine, vitamin K, warfarin, omeprazole, midazolam, repaglinide and bupropionGroup A: Caffeine, vitamin K, warfarin, omeprazole, and midazolam with or without fluzoparib Group B: Repaglinide and bupropion with or without fluzoparib | Drug | fluzoparib |
Primary outcome
Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion
Time frame: DAY1, DAY22
Peak Plasma Concentration (Cmax)
Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion
Time frame: DAY1, DAY22
Area under the plasma concentration versus time curve (AUC)
2 secondary outcomes
Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion
Time frame: DAY1,DAY 22
Number of Participants With Treatment-Related Adverse Events
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Wang, Ph.D. principal investigator
Hunan Cancer Hospitol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fluzoparib in people with Recurrent Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameters of caffeine, S-warfarin, omeprazole, midazolam, repaglinide, bupropion and hydroxybupropion (time frame: DAY1, DAY22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.