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

NCT03075462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2022-07-01

No results posted yet for this study

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

DRUG

Fluzoparib

Fluzoparib either at 40,60,80mg twice daily,capsule oral.

DRUG

Apatinib

Apatinib at 250mg once daily, tablet oral

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER
  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2021-08-22
Completion
2021-12-13

Countries

  • China

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075462 on ClinicalTrials.gov