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

Completed · Phase 1

Conditions studied: Metastatic Breast Cancer

In brief

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

Key facts

Study ID

NCT01973309

Run by

OncoMed Pharmaceuticals, Inc.

People needed

37

Starts

2013-09-01

Expected to finish

2017-12-01

Last updated by the study team

2020-09-09

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology-Tyler — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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