Ovarian Cancer
Conditions
Brief summary
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).
Interventions
Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
DRUGApatinib
Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity
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. Female patients, ≥18 Years. 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 0-2
Exclusion criteria
1. Non-epithelial tumours 2. Ovarian tumours with low malignant potential 3. Surgery (including open biopsy) within 4 weeks before starting study therapy or anticipated need for major surgery during study treatment 4. Evidence of rectosigmoid involvement by pelvic examination, bowel involvement on computed tomography, or clinical symptoms of bowel obstruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) by investigator | up to 2 years | ORR was defined as the proportion of subjects who have a complete or partial response relative to baseline . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AEs+SAEs | 30 days after the last dose | Frequency and severity of Adverse Events or Serious Adverse Events as defined by CTCAE version 5.0 |
| PFS by investigator | up to 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. |
| Overall Survival (OS) | up to 3 years | OS is the time interval from the date of randomization to death from any cause. |
| Pharmacokinetic characteristic | up to 2 years | Evaluation of PK parameters Tmax of apatinib or etoposide in plasma |
Contacts
Primary ContactZhaoyu Zhong, M.M
Backup ContactFenglin She, M.M
Outcome results
None listed