Study to Evaluate the Mass Balance and Biotransformation of [14C]-Fluzoparib in Chinese Patients With Solid Tumor

NCT ID: NCT04013048

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2019-12-24

Brief Summary

Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]-FZPL in Chinese Patients with Solid Tumor

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[14C]-Fluzoparib

Patients will receive single dose of \[14C\]- Fluzoparib.

Group Type: EXPERIMENTAL

[14C]-Fluzoparib

Intervention Type: DRUG

Patients will receive single dose of orally \[14C\]- Fluzoparib on Day 1.

Interventions

[14C]-Fluzoparib

Patients will receive single dose of orally \[14C\]- Fluzoparib on Day 1.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects diagnosed with advanced solid malignancies who are refractory or intolerant to standard therapy or considered to be benefit from the treatment of fluzoparib.

2. ECOG performance status of 0 to 1.

3. Life expectancy of more than 3 months.

4. Signing the informed consent forms.

5. Adequate bone marrow, liver and renal function.

6. Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.

Exclusion Criteria

1. Subjects who take any drugs that strongly inhibit or induce the CYP450 enzyme 14 days prior to study drug administration；

2. 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；

3. Subjects who smoked daily >5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study.

4. 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.

5. 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.

6. 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.

7. Subjects who have fertility planning within the range of starting trial - 1 year after finishing trial.

8. 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.

9. Subjects who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.

10. Subjects must not have had prior treatment with PARP inhibitors.

11. Subjects who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

FZPL-I-107

Identifier Type: -

Identifier Source: org_study_id