Status:
COMPLETED
Study to Evaluate the Mass Balance and Biotransformation of [14C]-Fluzoparib in Chinese Patients With Solid Tumor
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Study to Evaluate the Mass Balance and Biotransformation of Single Dose \[14C\]-FZPL in Chinese Patients with Solid Tumor
Eligibility Criteria
Inclusion
- 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.
- Adequate bone marrow, liver and renal function.
- Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.
Exclusion
- 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.
- Subjects who were used to drink grapefruit juice or overconsumption of tea, coffee, and the drink with caffeine; and cannot give up them during test.
- Subjects who need long-term exposure to radiation, or who have been exposed to PET-CT or ECT within 3 months prior to study drug administration or who have participated in the labeling test of radiopharmaceuticals.
- Subjects who have fertility planning within the range of starting trial - 1 year after finishing trial.
- Subjects who have excessive bleeding or blood donation (400ml) 3 months prior to screening period, or planned to donate blood 1 month after finishing this trial.
- Subjects who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
- Subjects must not have had prior treatment with PARP inhibitors.
- Subjects who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04013048
Start Date
July 8 2019
End Date
December 24 2019
Last Update
July 31 2020
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006