A Phase 1 interventional study of Vantictumab combined with paclitaxel in Metastatic Breast Cancer, sponsored by OncoMed Pharmaceuticals, Inc.. Completed at 4 sites in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by OncoMed Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 37 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →OncoMed Pharmaceuticals, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
o Patients with breast cancer overexpressing HER2 are not eligible.
Exclusion Criteria:
Drug: vantictumab combined with paclitaxel - administered intravenously
Drug: Vantictumab combined with paclitaxel
Vantictumab combined with paclitaxel will be administered IV.
Also known as: (OMP-18R5)
Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer
The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel
Time frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days).
Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer
Apparent half life, AUC, clearance, volume of distribution
Time frame: Plasma sample for Pharmacokinetics (PK) analysis to be obtained prior to the vantictumab infusion on Days 0, 14, 56 and 70 and at the end of the vantictumab infusion with paclitaxel infusion on Days 0 and 56.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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OncoMed Pharmaceuticals, Inc.