Advanced Solid MalignanciesPhase 1NCT02575651
A Phase I Study of Fluzoparib in Patient With Advanced Solid Malignancies
A Phase 1 study testing Fluzoparib in people with Advanced Solid Malignancies, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this study will be to investigate the safety and tolerability of Fluzoparib Capsule when given orally to Chinese patients with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- Fluzoparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2015to Jun 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- At least one measurable lesion exists.(RECIST 1.1).
- Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
- Subjects who have overall good overall general condition.
- Signed informed consent.
Who cannot join
- Subjects who received any previous treatment with a PARP inhibitor.
- Less than 4 weeks from the last clinical trial.
- Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hermone treatment and target therapy.
- Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
- Subjects with symptomatic uncontrolled brain metastases.
- Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
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- Subjects with a known hypersensitivity to Fluzoparib or any of the excipients of the product.
- Ongoing infection (determined by investigator).
- History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
- Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
- Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
Trial locations and contacts
2 sites in 1 country.
China2 sites
No.307 Hospital, Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100039
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of Fluzoparib Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignancies
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this study will be to investigate the safety and tolerability of Fluzoparib Capsule when given orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.
- Conditions
- Advanced Solid Malignancies
- Being tested
- Fluzoparib
- Keywords
- PARP, Advanced Solid Malignancies, Fluzoparib, Ovarian Cancer, BRCA
- 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
Fluzoparib either at 10,20,40,80,120mg ....., capsule oral.
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib | Experimental | Each subject will receive a single dose of fluzoparib on day 1, and then subject will receive fluzoparib twice daily for 28 days during cycle 1. Receives: Drug: Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.
Measured: 4 weeks
Secondary outcomes (6)
Evaluation of pharmacokinetic parameter of Fluzoparib: Cmax
Measured: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: Tmax
Measured: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: t1/2
Measured: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: AUC
Measured: 4 weeks
Preliminary antitumor activity for the regimen, objective response rate(ORR)
To evaluate ORR 8 weeks after the initiation of Fluzoparib
Measured: 8 weeks
Number of participants with adverse events.
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 307 Hospital of PLA, Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575651
- Sponsor's protocol ID
- HR-FZPL-I-AST-TOL/PK
- Status last verified
- Jun 2019
- First submitted
- 8 Oct 2015
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of Fluzoparib Following Single and Multiple Oral Doses in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT02575651
- Acronym / sponsor ID
- HR-FZPL-I-AST-TOL/PK
- Conditions
- Advanced Solid Malignancies
- Keywords
- PARP, Advanced Solid Malignancies, Fluzoparib, Ovarian Cancer, BRCA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- 307 Hospital of PLA, Peking University Cancer Hospital & Institute
- Study start
- Apr 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Oct 2015 (estimated)
- 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.
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this study will be to investigate the safety and tolerability of Fluzoparib Capsule when given orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib | Experimental | Drug: FluzoparibEach subject will receive a single dose of fluzoparib on day 1, and then subject will receive fluzoparib twice daily for 28 days during cycle 1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG performance status of 0 to 1.
- Life expectancy of more than 12 weeks.
- At least one measurable lesion exists.(RECIST 1.1).
- Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists.
- Subjects who have overall good overall general condition.
Key exclusion criteria (12 listed)
- Subjects who received any previous treatment with a PARP inhibitor.
- Less than 4 weeks from the last clinical trial.
- Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hermone treatment and target therapy.
- Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
- Subjects with symptomatic uncontrolled brain metastases.
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 |
|---|---|---|
| FluzoparibFluzoparib either at 10,20,40,80,120mg ....., capsule oral. | Drug | Fluzoparib |
Primary outcome
The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.
Time frame: 4 weeks
6 secondary outcomes
Evaluation of pharmacokinetic parameter of Fluzoparib: Cmax
Time frame: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: Tmax
Time frame: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: t1/2
Time frame: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: AUC
Time frame: 4 weeks
Preliminary antitumor activity for the regimen, objective response rate(ORR)
Time frame: 8 weeks
Number of participants with adverse events.
Time frame: 8 weeks
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 17 Jun 2019.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Advanced Solid Malignancies, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites 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 12 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle. (time frame: 4 weeks). 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 17 Jun 2019.