NCT01973309

A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer

A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: OncoMed Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.

Detailed description

Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined, up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the safety, tolerability and PK of vantictumab combined with paclitaxel. Up to approximately 34 patients may be enrolled into the study.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Vantictumab combined with paclitaxel	Vantictumab combined with paclitaxel will be administered IV.

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2013-10-31
• Last updated: 2020-09-09

Locations

4 sites across 1 country: United States