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 June 2015 by OncoMed Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01973309
First received: October 25, 2013
Last updated: September 8, 2015
Last verified: June 2015
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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). ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Apparent half life, AUC, clearance, volume of distribution


Estimated Enrollment: 34
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2015 (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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01973309

Locations
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    brenda.laabs@cshs.org   
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    anna.levin@ucdenver.edu   
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, Tammy.carmical@usoncology.com    214-370-1915      
Principal Investigator: Carlos H Becerra, MD         
Texas Oncology-Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Karen Poe    903-579-9869    karen.poe@usoncology.com   
Principal Investigator: Donald A Richards, MD         
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
  More Information

Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01973309     History of Changes
Other Study ID Numbers: 18R5-002 
Study First Received: October 25, 2013
Last Updated: September 8, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 30, 2016