TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Inclusion Criteria:

• 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, primaryperitoneal cancer, or fallopian tube cancer (Subjects with pseudomyxoma ,mesothelioma, unknown primary tumor, sarcoma, or neuroendocrine histology, withborderline ovarian cancer, ie, subjects with low malignant potential tumors, and withclear cell or mucinous histology are excluded)

• Subjects must have undergone surgery for ovarian cancer, primary peritoneal cancer, orfallopian tube cancer including at least a unilateral oophorectomy

• Radiologically evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with modifications

• Subjects must have had one prior platinum-based chemotherapeutic regimen formanagement of primary disease containing carboplatin, cisplatin, or anotherorganoplatinum compound. This initial treatment may have included intraperitonealtherapy, high-dose therapy, consolidation therapy, bevacizumab or extended therapyadministered after surgical or non-surgical assessment.

• Adequate organ and hematological function

• Generally well controlled blood pressure with systolic blood pressure <= 140 mmHg anddiastolic blood pressure <= 90 mmHg prior to randomization. The use ofanti-hypertensive medications to control hypertension is permitted

• Radiographically documented disease progression either on or following the last doseof prior chemotherapy regimen for epithelial ovarian cancer, primary peritonealcancer, or fallopian tube cancer

Exclusion Criteria:

• Subjects who have received more than 3 previous regimens of anti-cancer therapy forepithelial ovarian, primary peritoneal or fallopian tube cancers

• Subjects who have received paclitaxel as consolidation therapy, maintenance, ormonotherapy are excluded

• Subjects with primary platinum-refractory disease

• Subjects with platinum-free interval (PFI) > 12 months from their last platinum basedtherapy

• Radiotherapy <= 14 days prior to randomization. Subjects must have recovered from allradiotherapy-related toxicities

• Previous abdominal or pelvic radiotherapy

• History of arterial or venous thromboembolism within 12 months prior to randomization

• History of clinically significant bleeding within 6 months prior to randomization

• History of central nervous system metastasis

• Has not yet completed a 21 day washout period prior to randomization for any previousanti cancer systemic therapies (30 days for prior bevacizumab)

• Enrolled in or has not yet completed at least 30 days (prior to randomization) sinceending other investigational device or drug, or currently receiving otherinvestigational treatments

• Unresolved toxicities from prior systemic therapy that are Common Terminology Criteriafor Adverse Events (CTCAE) Version 3.0 >= Grade 2 in severity except alopecia

• Known active or ongoing infection (except uncomplicated urinary tract infection [UTI])within 14 days prior to randomization

• Currently or previously treated with AMG 386, or other molecules that inhibit theangiopoietins or Tie2 receptor

• Treatment within 30 days prior to randomization with strong immune modulatorsincluding but not limited to systemic cyclosporine, tacrolimus, sirolimus,mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, andlenalidomide

• Clinically significant cardiovascular disease within 12 months prior to randomization

• Major surgery within 28 days prior to randomization or still recovering from priorsurgery

• Minor surgical procedures, except placement of tunneled central venous access devicewithin 3 days prior to randomization. Diagnostic laparoscopy is regarded as a minorsurgical procedure.