Completed
A Phase I Mass Balance and Biotransformation Study of [14C]-Fluzoparib in Chinese Patients With Solid Tumor
What is being tested
[14C]-Fluzoparib
Drug
Who is being recruted
From 18 to 75 Years
+17 Eligibility Criteria
How is the trial designed
Other Study
Phase 1
Interventional
Study Start: July 2019
Summary
Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: July 8, 2019
Actual date on which the first participant was enrolled.Study to Evaluate the Mass Balance and Biotransformation of Single Dose \[14C\]-FZPL in Chinese Patients with Solid Tumor
Official TitleA Phase I Mass Balance and Biotransformation Study of [14C]-Fluzoparib in Chinese Patients With Solid Tumor
Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
6 inclusion criteria required to participate
Subjects diagnosed with advanced solid malignancies who are refractory or intolerant to standard therapy or considered to be benefit from the treatment of fluzoparib.
ECOG performance status of 0 to 1.
Life expectancy of more than 3 months.
Signing the informed consent forms.
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11 exclusion criteria prevent from participating
Subjects who take any drugs that strongly inhibit or induce the CYP450 enzyme 14 days prior to study drug administration；
Those who have history of alcohol abuse (it was defined as that the daily alcohol consumption was higher than the following criteria: the weekly alcohol consumption was higher than 14 units of alcohol (1 unit= 360 ml beers/45 ml liquor containing 40% alcohol/150ml grape wine) 6 months prior to screening period, or the alcohol breath test results ≥20 mg/dl during screening period；
Subjects who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study.
Subjects who have history of drug abuse or taking soft drug (i.e., marihuana) 3 months prior to screening period or taking hard drugs (i.e., cocaine, amphetamines, benzodiazepine, etc.); or the results of urine test in drugs were positive.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPatients will receive single dose of \[14C\]- Fluzoparib.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
The First Affiliated Hospital of Soochow University
Suzhou, ChinaOpen The First Affiliated Hospital of Soochow University in Google MapsCompletedOne Study Center