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Brief Title: A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer
Official Title: A Phase 1b Dose Escalation Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Breast Cancer
Study ID: NCT01973309
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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