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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity
Objective response rate (ORR) by investigator
ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline .
Time frame: up to 2 years
AEs+SAEs
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Time frame: 30 days after the last dose
PFS by investigator
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigator according to the RECIST criteria.
Time frame: up to 2 years
Overall Survival (OS)
OS is the time interval from the date of randomization to death from any cause.
Time frame: up to 3 years
Pharmacokinetic characteristic
Evaluation of PK parameters Tmax of apatinib or etoposide in plasma
Time frame: up to 2 years
Pharmacokinetic characteristic
Evaluation of PK parameters Cmax of apatinib or etoposide in plasma
Time frame: up to 2 years
Pharmacokinetic characteristic
Evaluation of PK parameters t1/2 of apatinib or etoposide in plasma
Time frame: up to 2 years
Pharmacokinetic characteristic
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Evaluation of PK parameters AUC0-t of apatinib or etoposide in plasma
Time frame: up to 2 years