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.
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)..
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
intravenous (in the vein) infusion
administered intravenously
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
Incidence of dose limiting toxicities (DLT)
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in subjects treated with OMP-305B83 in combination with Paclitaxel
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
Safety of OMP-30B583 in combination with Paclitaxel will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.
Time frame: Through study completion, an average of 6 months
To assess Immunogenicity (in terms of formation of anti-drug antibod(ies) against OMP-305B83 in percentage of subjects) of OMP-305B83 in combination with Paclitaxel
Time frame: Through study completion, an average of 6 months
Response Rate assessed by RECIST criteria 1.1
Time frame: At 56 day intervals while on treatment, through study completion, an average of 6 months
Response Rate assessed by CA-125 criteria
Time frame: At 28 day intervals while on treatment, through study completion, an average of 6 months
Progression Free Survival
Time frame: Up to 5 years
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