AMG 386 2nd Ovarian cancer Global Phase 3 clinical trial

INTERVENTION: investigational material(s) Generic name etc : AMG 386 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : ‐‐‐ Other Dosage and Administration for Investigational material : Intravenous CONDITION: Recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancers PRIMARY OUTCOME: PFS; Intergroup trial SECONDARY OUTCOME: OS; Intergroup trial INCLUSION CRITERIA: Major inclusion criteria include the following: ‐ Female 18 years of age or older at the time the written informed consent is obtained ‐ Gynecologic Oncology Group (GOG) Performance Status of 0 or 1 ‐ Life expectancy >= 3 months (per investigator opinion) �� Histologically or cytologically documented invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma , mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, with borderline ovarian cancer, ie, subjects with low malignant potential tumors, and with clear cell or mucinous histology are excluded) ‐ Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including at least a unilateral oophorectomy ‐ Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications (there must be radiographically visible tumor. Subjec