A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer

This is an open-label, Phase 1b dose escalation and expansion study of OMP-305B83 plus paclitaxel designed to evaluate the safety, efficacy and pharmacokinetics of OMP-305B83 in combination with paclitaxel in patients with platinum resistant ovarian, primary peritoneal or fallopian tube cancer. This study consists of a screening period, a treatment period and a post-treatment follow up period in which patients will be followed for survival for approximately 12 months. Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase.

Approximately 30 patients will be enrolled in this study at approximately 5 study centers in the United States (U.S)..

Inclusion criteria

• Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
• Measureable disease per response evaluation criteria (RECIST) v1.1
• Prior bevacizumab
• Age > or = 21 years
• Adequate organ and marrow function
• For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit.
• Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

• Treatment with any anti-cancer therapy, including radiotherapy, chemotherapy, biologic therapy. Prior therapy with weekly paclitaxel for recurrent disease, unless administered more than 2 years prior to enrollment, unless part of an upfront treatment strategy.
• History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, clinical signs or symptoms of gastrointestinaI obstruction or other known clinically signification gastrointestinal disease.
• Subjects with brain metastases
• Subjects with leptomeningial disease or neoplasms in the last 5 years
• Blood pressure >140/80
• Significant intercurrent illness that will limit the patient's ability to participate in the study
• Subjects with known metastases that are currently involving the lumen of the gastrointestinal tract.
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or anticipation of need for major surgical procedure during the course of the study
• Pregnant or nursing women
• New York Heart Association Classification II, III, or IV
• Inability to comply with study and follow up procedure