Loading clinical trials...

First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer

An Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Bevacizumab for Maintenance Therapy After First-line Platinum-containing Chemotherapy in BRCA Wild-type Advanced Ovarian Cancer

NCT06063070•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is an open-label, multi-center Phase II study of fluzoparib combined with bevacizumab for maintenance therapy after first-line platinum-containing chemotherapy in patients with BRCA wild-type advanced ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib plus bevacizumab.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent and ability to comply with treatment and follow-up.
•2. Age ≥ 18 years (Calculated on the date the informed consent was signed).
•3. Pathologically confirmed high-grade serous (or medium-low differentiation) or high grade endometrioid (≥ grade II) ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer:
•\- Mixed tumors: high-grade serous or high grade endometrioid (≥ grade II) component must be \>50%.
•4. Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III or IV of the 2018 FIGO classification) ovarian, fallopian tube, or primary peritoneal cancer; and underwent tumor reduction surgery.
•5. Patients must have received prior to enrollment a minimum of 6 cycles and a maximum of 9 cycles of first line platinum-taxane chemotherapy. However, if platinum-based therapy must be discontinued early as a result of intolerable toxicity, patients must have received a minimum of 4 cycles of the platinum regimen:
•-Preoperative neoadjuvant chemotherapy and postoperative chemotherapy counted as 1 chemotherapy treatment regimen.
•6. Patients must be prior to enrollment in complete response (CR) or partial response (PR) from their first line treatment, and use of the trial drug at least 3 weeks and no more than 9 weeks after their last dose of chemotherapy.
•* At least 4 cycles of the platinum regimen treatment were completed.
•* During or after platinum-containing chemotherapy, concurrent use of other investigational drugs and treatment other than endocrine therapy drugs are not permitted.
+14 more criteria

Exclusion Criteria

•1. Previous (within 5 years) or concurrent with other uncured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and breast cancer with no recurrence \>3 years after radical surgery;
•2. Patients with untreated central nervous system metastases:
•-Patients with prior treatment (radiotherapy or surgery) for systemic, radical brain or meningeal metastases may be enrolled if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose \>10mg/day prednisone or other equivocal hormone) has been discontinued for more than 2 weeks and who have no clinical evidence can be included;
•3. Any previous treatment with PARP inhibitor, including, olaparib, niraparib, rucaparib, pamiparib, and fluzoparib;
•4. Inability to swallow tablets properly or gastrointestinal function, may interfere with drug absorption, according to the investigator.
•5. Recent (within 3 months) occurrence of intestinal obstruction, gastrointestinal perforation;
•6. Patients with clinically symptomatic carcinomatous ascites or pleural effusion who need puncture or drainage or who have received drainage of ascites or pleural effusion within 2 months prior to the first trial of drug administration.
•7. Patients with clinically significant cardiovascular disease that are not well controlled, such as (1) New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF) (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) QTc \> 470ms;
•8. Patients with abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds), bleeding tendency, or who are receiving thrombolytic or anticoagulant therapy are permitted to receive low-dose low molecular heparin or oral aspirin for prophylactic anticoagulation during the trial;
•9. Patients who have experienced clinically significant bleeding symptoms or have a definite bleeding tendency within 3 months prior to the first dose, such as peptic bleeding, bleeding gastric ulcer, or suffering from vasculitis, etc., may be retested if the fecal occult blood is positive at the baseline period, and if it is still positive after the retesting, combined with the clinical judgment, and if necessary, gastroscopy will be carried out;
+10 more criteria

Locations (1)

Sun Yat-sen University Cancer Cetntre

Guangzhou, Guangdong, China

Key Dates

Start Date

October 18, 2023

Primary Completion Date

January 31, 2025

Completion Date

October 30, 2027

Last Updated

October 2, 2023

Enrollment

ESTIMATED participants

Conditions

Ovarian CancerHigh Grade Serous Adenocarcinoma of OvaryHigh Grade Endometrioid Ovarian CancerPrimary Peritoneal CancerFallopian-tube Cancer

Interventions

Fluzoparib Capsules

DRUG

Bevacizumab

DRUG

Contacts

Chunyan Lan

CONTACT

18928806306 lanchy@sysucc.org.cn

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

RECRUITINGPHASE1

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

NCT05039801

Advanced Endometrial CarcinomaAdvanced Head and Neck Squamous Cell Carcinoma+36 more

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 2, 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

First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery