Apatinib and Etoposide in Patients With Platinum Resistant or Refractory Ovarian Cancer

• Status: Completed
• Trial end date: 2019-09-10
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Apatinib; Etoposide; Etoposide phosphate

Criteria

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 bleeding diathesis or coagulopathy

• Inadequately controlled hypertension

• Major surgical procedure within 28 days prior to Day 1

• Symptomatic central nervous system (CNS) metastasis