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Trial record 1 of 4 for:    OMP-18R5
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A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by OncoMed Pharmaceuticals, Inc.
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc. Identifier:
First received: October 25, 2013
Last updated: January 23, 2017
Last verified: January 2017
This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and PK of vantictumab when combined with paclitaxel.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: Vantictumab combined with paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by OncoMed Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of vantictumab in combination with paclitaxel in patients with locally recurrent or metastatic breast cancer [ Time Frame: Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28 days). ]
    The maximum tolerated dose (MTD) will be determined in patients treated with vantictumab in combination with paclitaxel

Secondary Outcome Measures:
  • Pharmacokinetics (PK) of vantictumab when administered in combination with paclitaxel to patients with locally recurrent or metastatic breast cancer [ 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. ]
    Apparent half life, AUC, clearance, volume of distribution

Estimated Enrollment: 34
Study Start Date: September 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vantictumab combined with paclitaxel
Drug: vantictumab combined with paclitaxel - administered intravenously
Drug: Vantictumab combined with paclitaxel
Vantictumab combined with paclitaxel will be administered IV.
Other Name: (OMP-18R5)

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.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01973309

United States, California
Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Brenda Laabs    310-967-2781   
Principal Investigator: Monica Mita, MD         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Anna Levin    720-848-8031   
Principal Investigator: Jennifer Diamond, MD         
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Tammy Carmical,    214-370-1915      
Principal Investigator: Carlos H Becerra, MD         
Texas Oncology-Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Karen Poe    903-579-9869   
Principal Investigator: Donald A Richards, MD         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
  More Information

Responsible Party: OncoMed Pharmaceuticals, Inc. Identifier: NCT01973309     History of Changes
Other Study ID Numbers: 18R5-002
Study First Received: October 25, 2013
Last Updated: January 23, 2017

Keywords provided by OncoMed Pharmaceuticals, Inc.:
Locally Recurrent
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017