Loading clinical trials...

Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment

Fluzoparib Combined With Apatinib for Maintenance Treatment in Platinum-Sensitive Relapsed Ovarian Carcinoma: A Phase II Single-arm, Open Label, Multicenter Trial

NCT06081595•Jin Li

View on ClinicalTrials.gov

Summary

This study is a Phase II single-arm, open label, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma .

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient voluntarily joined the study and signed the informed consent.
•Age 18-75 years old.
•Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; Or moderately or poorly differentiated ovarian endometrioid adenocarcinoma.
•Previously, after undergoing 2-3 lines of platinum containing chemotherapy, CR or PR was achieved, and the time from the penultimate platinum containing chemotherapy to PD was ≥ 6 months.
•Patients who have received previous treatment with bevacizumab are acceptable.
•Allow previous treatment with PARP inhibitors other than Fluzoparib.
•ECOG score: 0-1.
•Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted) Absolute neutrophil count (ANC) ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥10g/dL Serum albumin ≥3g/dL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN
•Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during he study treatment period and within 2 months after the last administration of apatinib or 6 months after the last administration of fluzopril, whichever is longer; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period.

Exclusion Criteria

•Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, thyroid cancer, cervical carcinoma in situ and breast cancer with no recurrence \>3 years after radical surgery.
•The subject has untreated central nervous system metastasis.
•Inability to swallow pills normally, or gastrointestinal dysfunction, which may affect drug absorption according to the researchers.
•Recent (within 3 months) occurrence of intestinal obstruction.
•Patients with clinical symptoms of cancerous ascites and pleural effusion, who need puncture or drainage, or who have received ascites and pleural effusion drainage within 2 months before the first trial medication.
•Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention, (5) QTc\>470ms.
•Those with abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds), who have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy, are allowed to receive low-dose low-molecular weight heparin or oral aspirin prophylactic anticoagulant therapy during the trial.
•The subject has an active infection or unexplained fever \>38.5 degrees during the screening period and before the first dose;
•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).
•Those who had previously received radiotherapy, chemotherapy, endocrine therapy, or molecular targeted therapy and were enrolled less than 4 weeks after the completion of treatment (last dose); Adverse events (except alopecia) caused by previous treatment did not recover to ≤1 degree (CTCAE 5.0).
+4 more criteria

Key Dates

Start Date

October 30, 2023

Primary Completion Date

December 30, 2024

Completion Date

December 30, 2026

Last Updated

October 13, 2023

Enrollment

ESTIMATED participants

Conditions

Relapsed Ovarian Cancer

Interventions

Fluzoparib

DRUG

Apatinib

DRUG

OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

NCT04713514

Platinum-sensitive Ovarian CancerRelapsed Ovarian Cancer

View study

COMPLETEDPHASE2

A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

NCT04517357

Relapsed Ovarian Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Fluzoparib Combined With Apatinib in Relapsed Ovarian Carcinoma Maintenance Treatment

Inclusion Criteria

Exclusion Criteria

OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC

A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer

Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status