Ovarian Cancer
Conditions
Brief summary
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).
Interventions
DRUGApatinib
Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
DRUGEtoposide
Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
DRUGPaclitaxel
Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 Years and older 2. Epithelial ovarian, fallopian tube or primary peritoneal cancer 3. Platinum refractory and resistant disease (disease progression during platinum therapy or within 6 months of platinum therapy) 4. EOCG performance status of 0-1
Exclusion criteria
1. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy) 2. Known hypersensitivity to any of the study drugs or excipients. 3. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 4. Congenital or acquired immune deficiency (e.g. HIV infected)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) by independent review committee(IRC) | up to approximately 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS by investigator | up to approximately 2 years | 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 |
| Objective Response Rate (ORR) | up to approximately 2 years | 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. |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | up to approximately 2 years | Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0 |
| EQ-5D-5L questionnaire | up to approximately 2 years | EQ-5D-5L is a questionnaire that focus on issues specific to ovarian cancer. |
| FOSI-8 questionnaire | up to approximately 2 years | FOSI-8 is a questionnaire that focus on issues specific to ovarian cancer. |
| Overall Survival (OS) | up to approximately 3 years | OS is the time interval from the date of randomization to death from any cause. |
Countries
China
Contacts
Primary ContactZhaoyu Zhong, M.M
Backup ContactLanjun Zhao, Ph.D
Outcome results
None listed