Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer (NCT02867956) | Clinical Trial Compass
CompletedPhase 2
Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer
China35 participantsStarted 2016-08-10
Plain-language summary
The purpose of the study is to evaluate the efficacy and toxicity of apatinib in patients with platinum resistant or refractory ovarian cancer when combined with etoposide.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion Criteria:
* Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
* Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)
* At least treated with one line of platinum-based chemotherapy
* Female, age ≥18 years and ≤70 years, signed informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
* Patients must have a life expectancy of at least 3 months.
* Patients must have adequate organ function as defined by the following criteria:
* White blood cell count ≥ 3 x 10\^9/L, Absolute neutrophil count (ANC) (≥ 1.5 x 10\^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 70 x 10\^9/L
* Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2 x ULN
* Serum creatinine ≤ 1 x ULN
Exclusion Criteria:
* Had prior exposure to apatinib or has known allegies to any of the excipients.
* History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
* Patients with QT interval prolongation
* Serious, non-healing wound, active ulcer, bowel obstruction.
* History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1
* Evidence of bleedi…