An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer

June 23, 2005 updated by: Chugai Pharma USA

A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone

This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone.

The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • California
      • Concord, California, United States, 94520
        • Bay Area Cancer Research Group
      • Greenbrae, California, United States, 94904
        • California Cancer Care, Inc.
      • Los Angeles, California, United States
        • Institute of Cancer Therapies
      • Vista, California, United States, 92083
        • San Diego Cancer Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80010-0510
        • Anschutz Cancer Pavilion at the University of Colorado Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8028
        • Yale University
    • Florida
      • Ft. Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612-3824
        • Rush Cancer Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0098
        • University of Kentucky Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112-2278
        • Louisiana State University
    • Maryland
      • Frederick, Maryland, United States, 21701
        • Frederick Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Josephine Ford Cancer Center
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
      • Southfield, Michigan, United States, 48076
        • Southfield Oncology Institute, Inc.
    • Missouri
      • St. Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cancer Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • New Mexico Cancer Care Associates
    • New York
      • Bronx, New York, United States, 10467-2490
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11235
        • HemOnCare, P.C.
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • Syracuse, New York, United States, 12310
        • Suny Upstate Medical University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Cleveland, Ohio, United States, 44106
        • Ireland Cancer Center
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants, Inc.
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
      • Memphis, Tennessee, United States, 38104
        • Boston Baskin Cancer Group
      • Memphis, Tennessee, United States, 38104
        • The Boston Baskin Cancer Group
    • Texas
      • Corpus Christi, Texas, United States, 78412
        • Cancer Specialists Of South Texas, Pa
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research & Treatment
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Major Inclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you have/are:

  • Must be a female at least 18 years of age and be using an effective form of birth control.
  • A documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks.
  • A total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases.
  • You must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study.

Major Exclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

  • A change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic).
  • Received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period.
  • Used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug
  • Vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention.
  • Evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level > 10.1 mg/dL.
  • Use of any investigational drug within 30 days prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharma USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 16, 2003

First Submitted That Met QC Criteria

January 16, 2003

First Posted (Estimate)

January 17, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAL-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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