Status:
NOT_YET_RECRUITING
Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Epithelial Ovarian Cancer
Efficacy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 wi...
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. Subj...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06539091
Start Date
October 1 2024
End Date
October 1 2026
Last Update
August 6 2024
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