Relapsed Ovarian CancerPhase 2NCT04517357
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
A Phase 2 study testing Fluzoparib+Apatinib and Fluzoparib in people with Relapsed Ovarian Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Relapsed Ovarian Cancer
- What is being tested?
- Fluzoparib+Apatinib and Fluzoparib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2020to 1 Nov 2024
- Phase
- Phase 2
- 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 diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
- Patients must have received at least 2 previous platinum-containing regimens.
- At least one target lesion.
- ECOG performance status 0-1.
- Adequate bone marrow, kidney and liver function.
Who cannot join
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ，patients who received PARP inhibitor are eligible;
- Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;
- Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
- Known to be human immunodeficiency virus positive;
- Known active hepatitis C virus, or known active hepatitis B virus;
- Untreated and/or uncontrolled brain metastases;
- Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration;
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients
This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.
- Conditions
- Relapsed Ovarian Cancer
- Being tested
- Fluzoparib+Apatinib, 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.
Fluzoparib+ApatinibDrug
Fluzoparib-Apatinib combination
FluzoparibDrug
Fluzoparib monotherapy
Fluzoparib+ApatinibDrug
Fluzoparib-Apatinib combination
| Study group | Role | What they receive |
|---|---|---|
| Safety Lead-in or Parallel， Fluzoparib+Apatinib | Experimental | Participants will receive Fluzoparib-Apatinib combination until progression Receives: Drug: Fluzoparib+Apatinib |
| Fluzoparib monotherapy | Active comparator | Participants will receive Fluzoparib monotherapy until progression Receives: Drug: Fluzoparib |
| Exploratory cohort: Fluzoparib+Apatinib | Other | Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression Receives: Drug: Fluzoparib+Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
Measured: up to 28 days
(Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib
Measured: up to 28 days
(Phase 2) Objective response rate（ORR） in relapsed ovarian cancer patients
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Measured: Assessed up to a maximum of 20 months
(Exploratory research) Objective response rate（ORR） in relapsed ovarian cancer patients
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
Measured: Assessed up to a maximum of 20 months
Secondary outcomes (6)
AEs+SAEs
Adverse Events and Serious Adverse Events
Measured: from the first drug administration to within 30 days for the last treatment dose
Progression free survival (PFS)
Defined as Progression free survival per RECIST 1.1 criteria according to Investigator's assessment
Measured: up to 20 months
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Measured: up to 20 months
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Measured: up to 20 months
Response rate by RECIST 1.1 criteria
Measured: up to 20 months
Response rate by GCIG CA125
Measured: up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start16 Oct 2020
- Primary completion30 Nov 2023
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT04517357
- Sponsor's protocol ID
- FZPL-II-201
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2020
- Last updated
- 24 Feb 2025
- Results posted
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT04517357
- Acronym / sponsor ID
- FZPL-II-201
- Conditions
- Relapsed Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 18 Aug 2020 (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, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety Lead-in or Parallel， Fluzoparib+Apatinib | Experimental | Drug: Fluzoparib+ApatinibParticipants will receive Fluzoparib-Apatinib combination until progression |
| Fluzoparib monotherapy | Active comparator | Drug: FluzoparibParticipants will receive Fluzoparib monotherapy until progression |
| Exploratory cohort: Fluzoparib+Apatinib | Other | Drug: Fluzoparib+ApatinibParticipants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression |
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 diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer.
- Patients must have received at least 2 previous platinum-containing regimens.
- At least one target lesion.
- ECOG performance status 0-1.
- Adequate bone marrow, kidney and liver function.
Key exclusion criteria (8 listed)
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ，patients who received PARP inhibitor are eligible;
- Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed;
- Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration;
- Known to be human immunodeficiency virus positive;
- Known active hepatitis C virus, or known active hepatitis B virus;
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 |
|---|---|---|
| Fluzoparib+ApatinibFluzoparib-Apatinib combination | Drug | Safety Lead-in or Parallel， Fluzoparib+Apatinib |
| FluzoparibFluzoparib monotherapy | Drug | Fluzoparib monotherapy |
| Fluzoparib+ApatinibFluzoparib-Apatinib combination | Drug | Exploratory cohort: Fluzoparib+Apatinib |
Primary outcome
(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
Time frame: up to 28 days
(Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib
Time frame: up to 28 days
(Phase 2) Objective response rate（ORR） in relapsed ovarian cancer patients
Time frame: Assessed up to a maximum of 20 months
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
(Exploratory research) Objective response rate（ORR） in relapsed ovarian cancer patients
Time frame: Assessed up to a maximum of 20 months
Defined as Objective response rate per RECIST 1.1 criteria according to Investigator's assessment
6 secondary outcomes
AEs+SAEs
Time frame: from the first drug administration to within 30 days for the last treatment dose
Progression free survival (PFS)
Time frame: up to 20 months
Disease control rate (DCR)
Time frame: up to 20 months
Duration of response (DoR)
Time frame: up to 20 months
Response rate by RECIST 1.1 criteria
Time frame: up to 20 months
Response rate by GCIG CA125
Time frame: up to 20 months
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 24 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluzoparib+Apatinib and Fluzoparib in people with Relapsed 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 8 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 24 Feb 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle (time frame: up to 28 days). The study lists 4 primary outcomes in all. 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 24 Feb 2025.