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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04000295
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
  • Etoposide — DRUG
    Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
  • Paclitaxel — DRUG
    Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2

Study Details

The study is conducted to evaluate the efficacy, safety and tolerability of apatinib (375 mg qd) and etoposide capsule (50 mg/d, d1-14, q3w) in subjects with platinum resistant or refractory ovarian cancer compared with weekly paclitaxel (80 mg/m2, d1, d8, d15, q3w).

Key Dates

Start date
Aug 16, 2019
Status verified
Jun 2019
Primary completion
Jan 31, 2021
Completion
Jul 31, 2022

Study Design

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

Arms

  • Experimental: Apatinib and 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: Weekly Paclitaxel
    Weekly Paclitaxel (80 mg/m2, d1, d8, d15, q3w) until disease progression or intolerable toxicity

Primary Outcome Measure

Progression free survival(PFS) by independent review committee(IRC) [ Time Frame: up to approximately 2 years ]

Central Contacts

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