Solid TumorPhase 1NCT04013048

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

A Phase 1 study testing [14C]-Fluzoparib in people with Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumor
What is being tested?: [14C]-Fluzoparib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteChina
Study dates: 8 Jul 2019to 24 Dec 2019
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: A Phase I Mass Balance and Biotransformation Study of [14C]-Fluzoparib in Chinese Patients With Solid Tumor

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

Conditions: Solid Tumor
Being tested: [14C]-Fluzoparib
Keywords: Solid Tumor, 14C-Fluzoparib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04013048
Study group	Role	What they receive
[14C]-Fluzoparib	Experimental	Patients will receive single dose of [14C]- Fluzoparib. Receives: Drug: [14C]-Fluzoparib

What is being measured

The primary outcome is the main question the study is designed to answer.

The distribution of Fluzoparib in the whole blood and plasma and whole.radioactive pharmacokinetics following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
The percentage of radioactive dose of [14C] radiolabelled Fluzoparib recovered in blood and in total, up to Day 10 (approx).
Measured: Up to 10 days (approx) from the start of administration.
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor to obtain the mass balance data and the main excretion pathway in human body.
The percentage of radioactive dose of [14C] radiolabelled Fluzoparib recovered in urine, faeces and in total, up to Day 10 (approx).
Measured: Up to 10 days (approx) from the start of administration.
Identification of the main metabolite and biotransformation pathway of Fluzoparib and investigation of metabolite with proportion >10% in plasma following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
Proportion of different metabolites.
Measured: Up to 10 days (approx) from the start of administration.
Quantitive analysis of the concentrations of Fluzoparib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
The concentrations of Fluzoparib in plasma up to Day 10.
Measured: Up to 10 days (approx) from the start of administration.
Observation of safety following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
Adverse events assessed by CTCAE v5.0.
Measured: Up to 10 days (approx) from the start of administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 201924 Dec 2019

First posted9 Jul 2019
Study start8 Jul 2019
Primary completion24 Dec 2019
Study completion24 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04013048
Sponsor's protocol ID: FZPL-I-107
Status last verified: Jul 2019
First submitted: 7 Jul 2019
Last updated: 31 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Mass Balance and Biotransformation Study of [14C]-Fluzoparib in Chinese Patients With Solid Tumor
ClinicalTrials.gov ID: NCT04013048
Acronym / sponsor ID: FZPL-I-107
Conditions: Solid Tumor
Keywords: Solid Tumor, 14C-Fluzoparib
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 8 Jul 2019 (actual)
Primary completion: 24 Dec 2019 (actual)
Study completion: 24 Dec 2019 (actual)
First posted: 9 Jul 2019 (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.

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
[14C]-Fluzoparib	Experimental	Drug: [14C]-FluzoparibPatients will receive single dose of [14C]- Fluzoparib.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (11 listed)

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.

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

Primary outcome

The distribution of Fluzoparib in the whole blood and plasma and whole.radioactive pharmacokinetics following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
Time frame: Up to 10 days (approx) from the start of administration.
The percentage of radioactive dose of [14C] radiolabelled Fluzoparib recovered in blood and in total, up to Day 10 (approx).
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor to obtain the mass balance data and the main excretion pathway in human body.
Time frame: Up to 10 days (approx) from the start of administration.
The percentage of radioactive dose of [14C] radiolabelled Fluzoparib recovered in urine, faeces and in total, up to Day 10 (approx).
Identification of the main metabolite and biotransformation pathway of Fluzoparib and investigation of metabolite with proportion >10% in plasma following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
Time frame: Up to 10 days (approx) from the start of administration.
Proportion of different metabolites.
Quantitive analysis of the concentrations of Fluzoparib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
Time frame: Up to 10 days (approx) from the start of administration.
The concentrations of Fluzoparib in plasma up to Day 10.
Observation of safety following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor.
Time frame: Up to 10 days (approx) from the start of administration.
Adverse events assessed by CTCAE v5.0.

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 31 Jul 2020.
Individual participant dataSharing planned: Undecided

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

The record lists no contact. Use the official record to reach the sponsor.

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 [14C]-Fluzoparib in people with Solid Tumor, 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 6 inclusion and 11 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 31 Jul 2020. 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?

The distribution of Fluzoparib in the whole blood and plasma and whole.radioactive pharmacokinetics following the single orally administered [14C]-Fluzoparib in Chinese patients with advanced solid tumor. (time frame: Up to 10 days (approx) from the start of administration.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04013048.

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 31 Jul 2020.