Clinical Trials Directory

Trials / Completed

CompletedNCT03075462

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
98 (actual)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
Sex
Female
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGFluzoparibFluzoparib either at 40,60,80mg twice daily,capsule oral.
DRUGApatinibApatinib at 250mg once daily, tablet oral

Timeline

Start date
2017-03-09
Primary completion
2021-08-22
Completion
2021-12-13
First posted
2017-03-09
Last updated
2022-07-01

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03075462. Inclusion in this directory is not an endorsement.