Ovarian CancerPhase 1NCT03509636
A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
A Phase 1 study testing Fluzoparib in people with Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- 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
- 113 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2018to 23 Jul 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of high grade serous or Grade 2/3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer；
- Confirmed documented BRCA1/2 mutation;
- Received 2~4 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen；
- Relapsed/progressive disease as confirmed by radiologic assessment；
- Have measurable disease as defined by RECIST v1.1.
Who cannot join
- Any previous treatment with a PARP inhibitor;
- Patient with any other malignancy which has been active or treated within the previous 5 years;
- Patients with symptomatic uncontrolled brain metastases;
- Patients unable to swallow orally administered medication.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
Official title: An Open-Label Study to Assess the Efficacy And Safety of Poly(ADP-ribose) Polymerase Inhibitor Fluzoparib（SHR3162）in Patients With Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer and BRCA1/2 Mutation
This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.
Read the detailed description
Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) 1/2 being developed for treatment of BRCA1/2-mutant solid tumor. The tolerability, safety and PK of fluzoparib has been evaluated in Phase 1 study. An oral formulation is the focus of current development efforts.
- Conditions
- Ovarian Cancer
- Being tested
- Fluzoparib
- 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
Also called SHR-3162
Fluzoparib capsule will be given twice daily orally
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Fluzoparib capsule Receives: Drug: Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR by RECIST v1.1
Objective response rate
Measured: every 8 weeks (±7 days) of treatment
Secondary outcomes (6)
DoR
Duration of response
Measured: study data collection expected to last for ~2 years
PFS
Progression free survival
Measured: expected to last for ~2 years
Response rate by GCIG CA-125
Response rate per GCIG CA-125
Measured: every 8 weeks (±7 days) of treatment expected to last for ~2 years
OS
Overall suvival
Measured: study data collection expected to last for ~2 years
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications
per CTC AE 4.03
Measured: Every day starting with signing of consent until 30 days after discontinuation of treatment
Trough (Cmin) level of fluzoparib concentrations
Cssmin of fluzoparib concentrations
Measured: Cycle 1 to cycle 4(each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start4 Apr 2018
- Primary completion26 Aug 2019
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509636
- Sponsor's protocol ID
- HR-FZPL-Ⅰb-OC
- Status last verified
- Jun 2022
- First submitted
- 25 Feb 2018
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Efficacy And Safety of Poly(ADP-ribose) Polymerase Inhibitor Fluzoparib（SHR3162）in Patients With Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer and BRCA1/2 Mutation
- ClinicalTrials.gov ID
- NCT03509636
- Acronym / sponsor ID
- HR-FZPL-Ⅰb-OC
- Conditions
- Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 26 Apr 2018 (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.
This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.
Detailed description
Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) 1/2 being developed for treatment of BRCA1/2-mutant solid tumor. The tolerability, safety and PK of fluzoparib has been evaluated in Phase 1 study. An oral formulation is the focus of current development efforts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: FluzoparibFluzoparib capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of high grade serous or Grade 2/3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer；
- Confirmed documented BRCA1/2 mutation;
- Received 2~4 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen；
- Relapsed/progressive disease as confirmed by radiologic assessment；
- Have measurable disease as defined by RECIST v1.1.
Key exclusion criteria (4 listed)
- Any previous treatment with a PARP inhibitor;
- Patient with any other malignancy which has been active or treated within the previous 5 years;
- Patients with symptomatic uncontrolled brain metastases;
- Patients unable to swallow orally administered medication.
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 |
|---|---|---|
| FluzoparibAlso: SHR-3162Fluzoparib capsule will be given twice daily orally | Drug | Treatment |
Primary outcome
ORR by RECIST v1.1
Time frame: every 8 weeks (±7 days) of treatment
Objective response rate
6 secondary outcomes
DoR
Time frame: study data collection expected to last for ~2 years
PFS
Time frame: expected to last for ~2 years
Response rate by GCIG CA-125
Time frame: every 8 weeks (±7 days) of treatment expected to last for ~2 years
OS
Time frame: study data collection expected to last for ~2 years
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications
Time frame: Every day starting with signing of consent until 30 days after discontinuation of treatment
Trough (Cmin) level of fluzoparib concentrations
Time frame: Cycle 1 to cycle 4(each cycle is 28 days)
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 1 Jul 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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 Fluzoparib in people with Ovarian Cancer, 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 5 inclusion and 4 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 1 Jul 2022. 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?
ORR by RECIST v1.1 (time frame: every 8 weeks (±7 days) of treatment). 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 1 Jul 2022.