Epithelial Ovarian CancerPhase 3NCT06539091
Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer
A Phase 3 study testing Fluzoparib and Apatinib Mesylate in people with Epithelial Ovarian Cancer and Efficacy, run by Anhui Provincial Hospital.
Trial summary
This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Efficacy, Safety
- What is being tested?
- Fluzoparib and Apatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2026
- Phase
- Phase 3
- 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
- ECOG PS: 0-1;
- Initially treated patients with histologically or cytologically confirmed high-grade plasma ovarian cancer (HGSOC), fallopian tube cancer, primary peritoneal cancer, or endometrioid carcinoma of the ovary with FIGO stage III-IV;
- No prior maintenance therapy with PARP inhibitors; ④Final use of a combination chemotherapy regimen of bevacizumab, paclitaxel and carboplatin; ⑤Good function of major organs; ⑥Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and cooperated with follow-up visits; ⑦The modeled CA-125 ELIMination rate constant K (KELIM) ≥ 1.
Who cannot join
- Patients concurrently enrolled in other clinical trials;
- Previous maintenance therapy with PARP inhibitors combined with anti-angiogenic drugs;
- Previous history of allergic reaction, hypersensitivity reaction, intolerance to antibody-based drugs;
- Previous significant allergy to drugs or food or other substances;
- Subjects with untreated CNS metastases, previously treated with systemic, radical brain or meningeal metastases (radiotherapy or surgery), may be included if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose >10mg/day prednisone or other isotonic hormones) has been discontinued for >2 weeks without clinical evidence;
- Those who are unable to swallow tablets normally, or have abnormal gastrointestinal function that, in the judgment of the investigator, may interfere with drug absorption;
Show all 9Show fewer
- Have experienced clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months prior to randomization, such as peptic bleeding, bleeding gastric ulcer or suffering from vasculitis, etc. If the fecal occult blood is positive at the baseline period, it can be reviewed, and if it is still positive after review, combined with the clinical judgment, and if necessary, gastroscopy can be performed; ⑧The presence of currently uncontrolled malignant pleural fluid, ascites or pericardial effusion (defined as not effectively controlled by diuretics or puncture, as judged by the investigator);
- Presence of uncontrolled comorbidities including, but not limited to: active HBV or HCV infection, known HIV infection or history of AIDS, active syphilis, active tuberculosis, active infections, uncontrolled hypertension, symptomatic cardiac insufficiency, and active bleeding;
- Previous (within 5 years) or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence > 3 years after completion of radical surgery; ⑪Women during pregnancy or lactation; ⑫Having taken a drug that clearly affects the study drug within 30 days or 5 half-lives (whichever is longer) prior to enrollment; ⑬In the judgment of the investigator, the subject has other factors that may cause this study to be forcibly terminated midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the subject's safety, or the collection of data and samples.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-Arm, Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer (FAT-1)
This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer.
Patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate.
The study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.
Read the detailed description
During the treatment period, subjects were given fluazoparib capsules orally, two capsules/dose (50mg/capsule) twice daily, taken orally in the morning and in the evening, as a continuous dosage. Subjects will also receive oral apatinib mesylate tablets, one tablet/dose (250 mg/tablet), once daily, continuously. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment.
Safety evaluations will be performed on Day 1 of each 3-week treatment cycle (vital signs, physical examination, laboratory examination, physical status score and BMD testing); imaging evaluations and once CA125 test will be performed every 6 weeks for the first 24 weeks of dosing, and every 9 weeks thereafter to assess efficacy, and for 12 months or until an event occurs that meets the criteria for treatment discontinuation. Dose suspension or downward adjustment may be made during the study period based on the occurrence of adverse events in subjects.
- Conditions
- Epithelial Ovarian Cancer, Efficacy, Safety, Bone Mineral Density, Tolerability
- Being tested
- Fluzoparib, Apatinib Mesylate
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
The study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment.
Apatinib MesylateDrug
The study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are also required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment.
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib group | Experimental | During the treatment period, subjects were given fluazoparib capsules orally, two capsules/dose (50mg/capsule) twice daily, taken orally in the morning and in the evening, as a continuous dosage. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment. Receives: Drug: Fluzoparib |
| Apatinib Mesylate group | Experimental | During the treatment period, subjects will also receive oral apatinib mesylate tablets, one tablet/dose (250 mg/tablet), once daily, continuously. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment. Receives: Drug: Apatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free Survival (PFS) is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.
Measured: 2 year
Secondary outcomes (5)
OS
Overall Survival (OS) was defined as the time interval between a patient's diagnosis of gynecologic malignancy and death from any cause or the end of the last follow-up date.
Measured: 2 year
DOR
Duration Of Response (DOR) is defined as the time from when a patient reaches first remission (including complete or partial remission) to when the disease re-progresses.
Measured: 2 year
QoL
Quality of Life Score (QoL) is a score that assesses a patient's overall physical, psychological, social, and environmental well-being through a standardized questionnaire or scale.The scale has a full score of 60, with a very poor score of <20, a poor score of 21-30, a fair score of 31-40, a better score of 41-50, and a good score of 51-60.
Measured: 2 year
PFS-2
Progression-Free Survival 2 (PFS-2) defined as the time from patient randomization to completion of secondary therapy after disease re-progression or patient death.
Measured: 2 year
AE
Adverse events (AE) are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ying Zhou, MD, Study chair, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539091
- Sponsor's protocol ID
- Zhou ying-FAT-1
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer (FAT-1)
- ClinicalTrials.gov ID
- NCT06539091
- Acronym / sponsor ID
- Zhou ying-FAT-1
- Conditions
- Epithelial Ovarian Cancer, Efficacy, Safety, Bone Mineral Density, Tolerability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 6 Aug 2024 (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 study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer.
Patients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate.
The study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.
Detailed description
During the treatment period, subjects were given fluazoparib capsules orally, two capsules/dose (50mg/capsule) twice daily, taken orally in the morning and in the evening, as a continuous dosage. Subjects will also receive oral apatinib mesylate tablets, one tablet/dose (250 mg/tablet), once daily, continuously. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment.
Safety evaluations will be performed on Day 1 of each 3-week treatment cycle (vital signs, physical examination, laboratory examination, physical status score and BMD testing); imaging evaluations and once CA125 test will be performed every 6 weeks for the first 24 weeks of dosing, and every 9 weeks thereafter to assess efficacy, and for 12 months or until an event occurs that meets the criteria for treatment discontinuation. Dose suspension or downward adjustment may be made during the study period based on the occurrence of adverse events in subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib group | Experimental | Drug: FluzoparibDuring the treatment period, subjects were given fluazoparib capsules orally, two capsules/dose (50mg/capsule) twice daily, taken orally in the morning and in the evening, as a continuous dosage. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment. |
| Apatinib Mesylate group | Experimental | Drug: Apatinib MesylateDuring the treatment period, subjects will also receive oral apatinib mesylate tablets, one tablet/dose (250 mg/tablet), once daily, continuously. Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ECOG PS: 0-1;
Key exclusion criteria (9 listed)
- Patients concurrently enrolled in other clinical trials;
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 |
|---|---|---|
| FluzoparibThe study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment. | Drug | Fluzoparib group |
| Apatinib MesylateThe study treatment was followed by a 3-week treatment cycle. First day of each dosing cycle, subjects are also required to complete various examinations, including vital signs, physical examination, laboratory examination, physical status score, and BMD testing to evaluate the safety and tolerability of continued treatment. | Drug | Apatinib Mesylate group |
Primary outcome
PFS
Time frame: 2 year
Progression-Free Survival (PFS) is defined as the time interval between a patient's diagnosis of gynecological malignancy and the first occurrence of progression of the disease or death from any cause.
5 secondary outcomes
OS
Time frame: 2 year
DOR
Time frame: 2 year
QoL
Time frame: 2 year
PFS-2
Time frame: 2 year
AE
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
Related trials for Epithelial 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
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
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.
Ying Zhou, MD study chair
The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluzoparib and Apatinib Mesylate in people with Epithelial Ovarian Cancer and Efficacy, run by Anhui Provincial Hospital.
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 3 inclusion and 9 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ying Zhou, MD (13865901025, caddiezy@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 2 year). 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 6 Aug 2024.