NCT03030287

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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)..

Conditions

• Cancer Ovaries
• Cancer Peritoneal
• Cancer, Fallopian Tube

Interventions

Type	Name	Description
DRUG	OMP-305B83	intravenous (in the vein) infusion
DRUG	Paclitaxel	administered intravenously

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2017-01-25
• Last updated: 2020-09-03

Locations

7 sites across 1 country: United States