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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03075462
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Fluzoparib — DRUG
    Fluzoparib either at 40,60,80mg twice daily,capsule oral.
  • Apatinib — DRUG
    Apatinib at 250mg once daily, tablet oral

Study Details

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.

Key Dates

Start date
Mar 9, 2017
Status verified
Jun 2022
Primary completion
Aug 22, 2021
Completion
Dec 13, 2021

Study Design

Enrollment
98 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fluzoparib + Apatinib
    Fluzoparib and apatinib will be separately administered to patients on the 1st and 4th day, respectively. Then from the 7th day they are administered continuously and orally in combination, 28 days per cycle, until disease progression or unacceptable toxicity.

Primary Outcome Measure

The type and incidence of adverse events [safety and tolerability] [ Time Frame: From screening up to 28 days after end of treatment ]

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