Loading clinical trials...

A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

An Open, Non-randomised, Multi-centre Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination With Apatinib in Patients With Recurrent Ovarian Cancer or Triple Negative Breast Cancer

NCT03075462•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
•Life expectancy of more than 12 weeks.
•Histologically or cytologically confirmed high-grade papillary-serous epithelial ovarian cancer，primary peritoneal, or fallopian tube cancers; subjects with a known deleterious breast cancer gene (BRCA) mutation and any other high-grade histology are also eligible. Subjects should have platinum-sensitive disease, where platinum-sensitive disease is defined as having had a \> 6 month interval since last receiving platinum therapy prior to disease recurrence. Additionally, subjects with histologically or cytologically confirmed triple negative breast cancer (TNBC）, that is locally advanced or metastatic, are also eligible.
•Prior therapy：subjects with ovarian cancer，primary peritoneal, or fallopian tube cancers have received only 2 lines of platinum-based chemotherapies, and TNBC patients have received only 1 line of standard chemotherapy. Each prior chemotherapy must be given for at least 2 cycles.
•At least one measurable lesion that can be accurately assessed by imaging (CT/MRI) at baseline
•Subjects who have overall good overall general condition.
•Signed informed consent.

Exclusion Criteria

•Subjects who received any previous treatment with any PARP inhibitors.
•Subjects who received any previous treatment with any VEGFR inhibitors.
•Less than 4 weeks from the last clinical trial.
•Less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment and target therapy.
•Unstable or uncontrolled hypertension.
•Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption.
•Subjects with brain metastases.
•Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
•Subjects with a known hypersensitivity to fluzoparib, apatinib or any of the excipients of the products.
•Ongoing infection (determined by investigator).
+2 more criteria

Locations (1)

Beijing Cancer Hosptial

Beijing, Beijing Municipality, China

Key Dates

Start Date

March 9, 2017

Primary Completion Date

August 22, 2021

Completion Date

December 13, 2021

Last Updated

July 1, 2022

Enrollment

ACTUAL participants

Conditions

Ovarian CancerTriple Negative Breast Cancer

Interventions

Fluzoparib

DRUG

Apatinib

DRUG

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

RECRUITINGPHASE2

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

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: July 1, 2022Data 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

A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

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

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

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)

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer