A Phase 1 interventional study of OMP-305B83 and Paclitaxel in Cancer Ovaries, Cancer Peritoneal and Cancer, Fallopian Tube, sponsored by OncoMed Pharmaceuticals, Inc.. Completed at 7 sites in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by OncoMed Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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)..
720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.
This study's enrollment of 44 is below the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →OncoMed Pharmaceuticals, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: OMP-305B83 · Drug: Paclitaxel
intravenous (in the vein) infusion
Also known as: bispecific monoclonal antibody
administered intravenously
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
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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OncoMed Pharmaceuticals, Inc.