Recurrent Ovarian CancerPhase 2NCT05819060
The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab
A Phase 2 study testing Fuzuloparib Combination with Bevacizumab in people with Recurrent Ovarian Cancer, run by Fudan University at 1 site in China.
Trial summary
The study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Ovarian Cancer
- What is being tested?
- Fuzuloparib Combination with Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2023to 30 Mar 2025
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;
- Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy;
- Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;
- Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;
- The patient achieved a complete or partial response after the last platinum-based chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
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- The patient has a life expectancy of at least 3 months and sufficient organ function;
- The patient has sufficient bone marrow reserves and organ function, including a creatinine clearance rate of 45 mL/min calculated using the standard Cockcroft and Gault formula;
- The patient voluntarily agrees to participate in this study and signs an informed consent form.
Who cannot join
- Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;
- Patients who have undergone major surgery within 28 days prior to enrollment;
- Patients with central nervous system metastases or a history of seizures within the past 12 months;
- Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;
- NYHA functional class ≥ III;
- Patients with severe, uncontrolled systemic diseases;
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- Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study;
- Pregnant or lactating patients, or patients who cannot guarantee effective contraception during the study treatment period;
- Patients with poorly controlled neurological or psychiatric disorders or mental illness, poor compliance, and inability to cooperate or describe treatment response;
- Patients judged by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Cente
Shanghai, Shanghai Municipality, 200032
zheng zhong, MD, alizheng@126.com
About this study
Official title: The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab in Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer
The study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. The progression-free survival, OS, and safety were evaluated based on RECIST V1.1.
Read the detailed description
Due to the lack of effective predictive molecular markers in the maintenance treatment phase, it is difficult to assess the effectiveness of maintenance treatment. This project plans to collect blood and urine from subjects before maintenance treatment, during relapse, and for follow-up molecular marker exploration research.
- Conditions
- Recurrent Ovarian Cancer
- Being tested
- Fuzuloparib Combination with Bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzuloparib Combination with BevacizumabDrug
For the first 6 patients, if DLT≤33.3%, Fuzuloparib 150mg/bid will be used for follow-up research; if DLT>33.3%, Fuzuloparib will be used for follow-up research at 100mg/bid; Bevacizumab 7.5mg/kg, d1, Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Fuzuloparib Combination with Bevacizumab | Experimental | Fuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg，d1，Q3W Receives: Drug: Fuzuloparib Combination with Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
according to RECIST v1.1
Measured: approximately 1.5 years
Secondary outcomes (2)
Overall survival (OS)
according to RECIST v1.1
Measured: Up to approximately 1.5 years
Adverse Events (AEs)
According to CTCAE V5.0 criteria, During the trial, the adverse event record form should be truthfully filled in, including the occurrence time, severity, correlation with study treatment, duration, measures taken and outcome of the adverse event.
Measured: From the first drug administration to within 30 days for the last treatment dose]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start30 Apr 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong Zheng MD, Fudan University
- Investigators
- Zhong Zheng, Ph.D, Principal investigator, Department of Gynecologic Oncology, Fudan University Shanghai Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819060
- Sponsor's protocol ID
- 2023-02-3121
- Status last verified
- Apr 2023
- First submitted
- 19 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available per require after approved by ethics broad
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of The Fuzuloparib Combination With Bevacizumab in Maintenance Treatment for Platinum-Sensitive Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05819060
- Acronym / sponsor ID
- 2023-02-3121
- Conditions
- Recurrent Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 Apr 2023 (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.
The study will be a Prospective, Single-arm, Phase Ⅱ Clinical Study. This study intends to explore the efficacy and safety of Fuzuloparib combined with bevacizumab in the maintenance treatment of patients with platinum-sensitive ovarian cancer. The progression-free survival, OS, and safety were evaluated based on RECIST V1.1.
Detailed description
Due to the lack of effective predictive molecular markers in the maintenance treatment phase, it is difficult to assess the effectiveness of maintenance treatment. This project plans to collect blood and urine from subjects before maintenance treatment, during relapse, and for follow-up molecular marker exploration research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fuzuloparib Combination with Bevacizumab | Experimental | Drug: Fuzuloparib Combination with BevacizumabFuzuloparib 150mg/bid ; Bevacizumab 7.5mg/kg，d1，Q3W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with platinum-sensitive recurrent ovarian cancer confirmed by pathology or histology;
- Patients who have previously received platinum-based chemotherapy and had a recurrence interval of > 6 months before the last platinum-based chemotherapy;
- Patients who have previously received bevacizumab and did not experience progression within 3 months during the use of bevacizumab;
- Patients who have previously received PARP inhibitors and did not experience progression within 12 months during the use of PARP inhibitors;
- The patient achieved a complete or partial response after the last platinum-based chemotherapy;
Key exclusion criteria (10 listed)
- Patients who are known to be allergic or intolerant to chemotherapy drugs or their excipients and cannot swallow medication;
- Patients who have undergone major surgery within 28 days prior to enrollment;
- Patients with central nervous system metastases or a history of seizures within the past 12 months;
- Uncontrolled hypertension: systolic blood pressure ≥180mmHg, diastolic blood pressure ≥90mmHg;
- NYHA functional class ≥ III;
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 |
|---|---|---|
| Fuzuloparib Combination with BevacizumabFor the first 6 patients, if DLT≤33.3%, Fuzuloparib 150mg/bid will be used for follow-up research; if DLT>33.3%, Fuzuloparib will be used for follow-up research at 100mg/bid; Bevacizumab 7.5mg/kg, d1, Q3W. | Drug | Fuzuloparib Combination with Bevacizumab |
Primary outcome
Progression-free survival (PFS)
Time frame: approximately 1.5 years
according to RECIST v1.1
2 secondary outcomes
Overall survival (OS)
Time frame: Up to approximately 1.5 years
Adverse Events (AEs)
Time frame: From the first drug administration to within 30 days for the last treatment dose]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No. Data is available per require after approved by ethics broad
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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.
Zhong Zheng, Ph.D principal investigator
Department of Gynecologic Oncology, Fudan University Shanghai Cancer
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 Fuzuloparib Combination with Bevacizumab in people with Recurrent Ovarian Cancer, run by Fudan University 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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhong Zheng, Ph.D (02164175590 ext. 82900, alizheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: approximately 1.5 years). 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 19 Apr 2023.