A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer
This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.
• Willingness to sign a written informed consent document .
• Female, age ≥18 yrs and ≤70 yrs.
• Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.
• Patients with platinum refractory or platinum resistant ovarian cancer:
‣ Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;
⁃ Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks);
⁃ Radiological progression during the last treatment administered;
⁃ no more than 1 prior treatment regimens for recurrent disease.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• At least 1 lesion can be accurately measured, as defined by RECIST1.1.
• Laboratory criteria are as follows:
‣ Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets ≥90×109/L;
⁃ Biochemistry test: serum creatinine(cr) \<1.5×ULN; total bilirubin\<1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ;
⁃ Coagulation test: International Normalized Ratio (INR) \< 1.5, activeated partial thromboplasting time (APTT) \<1.5×ULN
• Life expectancy of at least 3 months.