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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OncoMed Pharmaceuticals, Inc.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Signed Informed Consent Form

• Age ≥18 years

• Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease

o Patients with breast cancer overexpressing HER2 are not eligible.

• Availability of tumor tissue, either archival FFPE or obtained at study entry through fresh biopsy

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• All acute treatment-related toxicity from prior therapy must have resolved to Grade ≤ 1 prior to study entry

• Adequate hematologic and end-organ function

• Evaluable or measurable disease per RECIST v1.1

• For women of childbearing potential, agreement to use two effective forms of contraception

Exclusion Criteria:

• Known significant dose delays during prior treatment with a taxane due to drug-related toxicities

• Prior treatment with more than two regimens of systemic cytotoxic chemotherapy for locally recurrent or metastatic disease

• Treatment with any anti-cancer therapy within 3 weeks prior to initiation of study treatment