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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression free survival(PFS) by independent review committee(IRC)
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 IRC according to the RECIST criteria
Time frame: up to approximately 2 years
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0
Time frame: up to approximately 2 years
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 approximately 2 years
Objective Response Rate (ORR)
Proportion of subjects who have a complete or partial response relative to baseline as assessed per RECIST 1.1 criteria as well as Gynecologic Cancer Intergroup (GCIG) cancer antigen (CA)-125 criteria.
Time frame: up to approximately 2 years
Overall Survival (OS)
OS is the time interval from the date of randomization to death from any cause.
Time frame: up to approximately 3 years
EQ-5D-5L questionnaire
EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer.
Time frame: up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
FOSI-8 questionnaire
FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer.
Time frame: up to approximately 2 years