Apatinib and Etoposide Capsule Versus Apatinib in Patients With Platinum Resistant Ovarian Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04383977
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib and Etoposide capsule — DRUG
    Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
  • Apatinib — DRUG
    Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity

Study Details

The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) or apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with apatinib (375 mg qd).

Key Dates

Start date
May 31, 2020
Status verified
May 2020
Primary completion
Dec 31, 2020
Completion
Jun 30, 2021

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib-Etoposide capsule
    Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
  • Active Comparator: Apatinib
    Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity

Primary Outcome Measure

Objective response rate (ORR) by investigator [ Time Frame: up to 2 years ]

Central Contacts

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