Ovarian Cancer Clinical Trial
A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer
Summary
The purpose of this study is to test the efficacy and safety of an experimental drug, OMP-305B83, when given in combination with paclitaxel. OMP-305B83 is a humanized monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread.
Full Description
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)..
Eligibility Criteria
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
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There are 7 Locations for this study
Aurora Colorado, 80045, United States
Tampa Florida, 33612, United States
Charlotte North Carolina, 28204, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19104, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
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