Spots Global Cancer Trial Database for A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer
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Trial Identification
Brief Title: A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer
Official Title: A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Study ID: NCT03030287
Study Description
Brief 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.
Detailed 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)..
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc. (Moffitt Cancer Center), Tampa, Florida, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
The University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
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