Ovarian CancerPhase 3NCT06188455
Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer
A Phase 3 study testing Fluzoparib Capsules and Apatinib Mesylate Tablets in people with Ovarian Cancer, run by The First Affiliated Hospital of Xiamen University.
Trial summary
Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Fluzoparib Capsules and Apatinib Mesylate Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 1. Age: 18 ≤75 years old, female; 2. Pathological (including histological) evidence of ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer (ovarian cancer); 3. Received first-line platinum drug chemotherapy in the past, the curative effect during the last treatment with platinum regimen (from the start of treatment to within 1 month after the last administration) was non-PD, and the recurrence/progression (platinum resistance) within 6 months after the end of treatment; Or recurrence or progression (platinum-sensitive) ≥6 months after the end of the last platinum-containing treatment; CR/PR/SD after at least 4 cycles of chemotherapy again; 4. According to RECIST1.1 criteria, the patient had at least one target lesion with measurable diameter (tumor lesion with CT scan length ≥10mm, lymph node lesion with CT scan short diameter ≥15mm, and scanning layer thickness 5mm); 5. ECOG PS 0-1 score; 6. Major organs function normally and meet the following criteria:
- The standard of blood routine examination must meet: (no blood transfusion within 14 days)
- HB≥100g/L,
- WBC≥3×109/L
- ANC≥1.5×109/L,
- PLT≥100×109/L;
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- Biochemical examination shall meet the following standards:
- BIL ≤1.5 times upper limit of normal value (ULN);
- ALT and AST≤2.5×ULN, and ALT and AST≤5×ULN in patients with liver metastasis;
- Serum Cr≤1.5×ULN. 7. International Standardized ratio (INR) OR prothrombin time (PT), activated partial thrombin activity time (aPTT)≤1.5 × ULN, unless the patient is receiving anticoagulant therapy, as long as PT or aPTT is within the therapeutic range of the anticoagulant drug intended to be used; 8. No serious heart, lung, liver, kidney disorders; 9. Women of reproductive age must undergo a pregnancy test (serological) within 7 days prior to enrollment, with a negative result, and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug; 10. The expected overall survival ≥6 months, post-treatment survival ≥3 months; 11. Sign a written informed consent and be able to comply with the visit and related procedures specified in the program.
Who cannot join
- Other clinical drug experiments in which other experimental drugs are used at the same time as the study;
- Other cancer treatments, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, microbiological therapy, traditional Chinese medicine therapy and other experimental therapies, were used in conjunction with this study;
- Patients who are known to be allergic to fluzoparil or to active or inactive components of the drug with a similar chemical structure;
- Patients who are known to be allergic to Apatinib or to active or inactive components of the drug with a similar chemical structure;
- Inability to swallow oral medications and any gastrointestinal disorders that may interfere with study drug absorption and metabolism, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;
- Symptomatic or uncontrolled brain metastases requiring concurrent treatment, including but not limited to surgery, radiation and/or corticosteroids, or clinical manifestations of spinal cord compression;
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- The subject has had other malignant diseases in the past 3 years, except cutaneous squamous cell carcinoma, basal-like carcinoma, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix;
- The patient has a prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);
- Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal perforation;
- Patients with clinical symptoms or diseases that are not well controlled, such as: (1) NYHA2 or above cardiac dysfunction, (2) unstable angina pectoris, (3) acute myocardial infarction occurred within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc>470ms;
- Any bleeding event with a severe CTCAE 5.0 rating of 2 or more occurring within 4 weeks prior to the initial trial administration;
- People with hypertension who are not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, institutionalized pneumonia, drug-induced pneumonia, or active pneumonia shown by CT during screening;
- Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds) who have bleeding tendencies or are receiving thrombolytic or anticoagulant therapy (including but not limited to patients requiring long-term anticoagulant therapy) are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial;
- Diagnosis of patients with deep vein thrombosis (except intermuscular vein thrombosis);
- Patients with a history of hereditary or acquired bleeding or coagulation disorders. There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months before the first trial, such as gastrointestinal bleeding and hemorrhagic gastric ulcer;
- Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA≥500 IU/ml; Hepatitis C reference: HCV antibody positive and HCV copy number > upper limit of normal);
- The patient received platelet or red blood cell transfusions within four weeks prior to initiation of treatment with the investigational drug;
- Patients who are pregnant or nursing, or who plan to become pregnant during the study treatment period.
- According to the researchers' judgment, the subjects have other factors that may lead to the forced termination of the study.
About this study
Official title: Clinical Study of Fluzopalil Combined With Apatinib for Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer
Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled
Read the detailed description
The subjects selected surgery according to the actual situation, and received chemotherapy containing platinum after surgery, totaling 4 cycles of chemotherapy. After the completion of the treatment course, the researchers will use fluzoparil combined with apatinib to maintain the treatment until the disease progression in patients with CR, PR and SD evaluated according to RECIST 1.1 efficacy.
The medication regimen for all enrolled patients was recommended as follows, and the dose could be adjusted during treatment due to adverse reactions and other circumstances:
Fluzopalil capsules:
Oral administration of 100 mg, 2 capsules/time (50 mg/capsule), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take oral administration in the morning and late 0.5h, continuous administration. Every 4 weeks is a treatment period.
Apatinib tablets:
Oral administration of 250 mg each time, 1 tablet/time (250 mg/tablet), it is recommended to take orally 0.5 h after breakfast, continuous administration. Every 4 weeks is a treatment period.
Treatment will continue until an event occurs that meets the criteria for treatment termination.
- Conditions
- Ovarian Cancer
- Being tested
- Fluzoparib Capsules, Apatinib Mesylate Tablets
- 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 CapsulesDrug
Oral administration of 100 mg, 2 capsules/time (50 mg/capsule), twice daily
Apatinib Mesylate TabletsDrug
Oral administration of 250 mg each time, 1 tablet/time (250 mg/tablet)
| Study group | Role | What they receive |
|---|---|---|
| Fuzuloparib With Apatinib Mesylate Tablets | Experimental | Not described Receives: Drug: Fluzoparib Capsules; Drug: Apatinib Mesylate Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
To evaluate the efficacy and safety of fluzoparil combined with apatinib for maintenance after platinum-containing chemotherapy in patients with recurrent ovarian cancer by progression-free survival (PFS).
Measured: up to12 months
Secondary outcomes (2)
ORR
Objective response rate (ORR) was used to evaluate the efficacy of fluzoparil combined with apatinib for maintenance after platinum-containing chemotherapy in patients with recurrent ovarian cancer
Measured: up to 12 months
OS
To evaluate the efficacy of fluzoparil combined with apatinib for maintenance after platinum-containing chemotherapy in patients with recurrent ovarian cancer by overall survival (OS)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
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 The First Affiliated Hospital of Xiamen 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188455
- Sponsor's protocol ID
- FJ-OC-021
- Status last verified
- Oct 2023
- First submitted
- 18 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Fluzopalil Combined With Apatinib for Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06188455
- Acronym / sponsor ID
- FJ-OC-021
- Conditions
- Ovarian Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Jan 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.
Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled
Detailed description
The subjects selected surgery according to the actual situation, and received chemotherapy containing platinum after surgery, totaling 4 cycles of chemotherapy. After the completion of the treatment course, the researchers will use fluzoparil combined with apatinib to maintain the treatment until the disease progression in patients with CR, PR and SD evaluated according to RECIST 1.1 efficacy.
The medication regimen for all enrolled patients was recommended as follows, and the dose could be adjusted during treatment due to adverse reactions and other circumstances:
Fluzopalil capsules:
Oral administration of 100 mg, 2 capsules/time (50 mg/capsule), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take oral administration in the morning and late 0.5h, continuous administration. Every 4 weeks is a treatment period.
Apatinib tablets:
Oral administration of 250 mg each time, 1 tablet/time (250 mg/tablet), it is recommended to take orally 0.5 h after breakfast, continuous administration. Every 4 weeks is a treatment period.
Treatment will continue until an event occurs that meets the criteria for treatment termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fuzuloparib With Apatinib Mesylate Tablets | Experimental | Drug: Fluzoparib Capsules, Drug: Apatinib Mesylate Tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Age: 18 ≤75 years old, female; 2. Pathological (including histological) evidence of ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer (ovarian cancer); 3. Received first-line platinum drug chemotherapy in the past, the curative effect during the last treatment with platinum regimen (from the start of treatment to within 1 month after the last administration) was non-PD, and the recurrence/progression (platinum resistance) within 6 months after the end of treatment; Or recurrence or progression (platinum-sensitive) ≥6 months after the end of the last platinum-containing treatment; CR/PR/SD after at least 4 cycles of chemotherapy again; 4. According to RECIST1.1 criteria, the patient had at least one target lesion with measurable diameter (tumor lesion with CT scan length ≥10mm, lymph node lesion with CT scan short diameter ≥15mm, and scanning layer thickness 5mm); 5. ECOG PS 0-1 score; 6. Major organs function normally and meet the following criteria:
Key exclusion criteria (20 listed)
- Other clinical drug experiments in which other experimental drugs are used at the same time as the study;
- Other cancer treatments, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, microbiological therapy, traditional Chinese medicine therapy and other experimental therapies, were used in conjunction with this study;
- Patients who are known to be allergic to fluzoparil or to active or inactive components of the drug with a similar chemical structure;
- Patients who are known to be allergic to Apatinib or to active or inactive components of the drug with a similar chemical structure;
- Inability to swallow oral medications and any gastrointestinal disorders that may interfere with study drug absorption and metabolism, such as uncontrolled nausea and vomiting, gastrointestinal obstruction, or malabsorption;
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 CapsulesOral administration of 100 mg, 2 capsules/time (50 mg/capsule), twice daily | Drug | Fuzuloparib With Apatinib Mesylate Tablets |
| Apatinib Mesylate TabletsOral administration of 250 mg each time, 1 tablet/time (250 mg/tablet) | Drug | Fuzuloparib With Apatinib Mesylate Tablets |
Primary outcome
PFS
Time frame: up to12 months
To evaluate the efficacy and safety of fluzoparil combined with apatinib for maintenance after platinum-containing chemotherapy in patients with recurrent ovarian cancer by progression-free survival (PFS).
2 secondary outcomes
ORR
Time frame: up to 12 months
OS
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluzoparib Capsules and Apatinib Mesylate Tablets in people with Ovarian Cancer, run by The First Affiliated Hospital of Xiamen University.
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 10 inclusion and 20 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: opening soon, as of the sponsor's last update on 3 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
PFS (time frame: up to12 months). 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 3 Jan 2024.