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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01973309
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Vantictumab combined with paclitaxel Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2013
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973309


Locations
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United States, California
Cedars-Sinai Medical Center/ Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-Tyler
Tyler, Texas, United States, 75702
Sponsors and Collaborators
OncoMed Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01973309    
Other Study ID Numbers: 18R5-002
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Keywords provided by Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. ):
Locally Recurrent
Metastatic Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action