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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00051779
Other study ID # CAL-03
Secondary ID
Status Completed
Phase Phase 1
First received January 16, 2003
Last updated June 23, 2005

Study information

Verified date February 2004
Source Chugai Pharma USA
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
CAL


Locations

Country Name City State
United States Anschutz Cancer Pavilion at the University of Colorado Cancer Center Aurora Colorado
United States Dana-Farber/Harvard Cancer Center Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States HemOnCare, P.C. Brooklyn New York
United States Rush Cancer Institute Chicago Illinois
United States Ireland Cancer Center Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Palmetto Health Columbia South Carolina
United States Hematology Oncology Consultants, Inc. Columbus Ohio
United States Bay Area Cancer Research Group Concord California
United States Cancer Specialists of South Texas, PA Corpus Christi Texas
United States Center for Oncology Research & Treatment Dallas Texas
United States Josephine Ford Cancer Center Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Frederick Memorial Hospital Frederick Maryland
United States Holy Cross Hospital Ft. Lauderdale Florida
United States Spectrum Health Grand Rapids Michigan
United States California Cancer Care, Inc. Greenbrae California
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States Baylor College of Medicine Houston Texas
United States Nevada Cancer Center Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States University of Kentucky Medical Center Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Institute of Cancer Therapies Los Angeles California
United States Boston Baskin Cancer Group Memphis Tennessee
United States The Boston Baskin Cancer Group Memphis Tennessee
United States The West Clinic Memphis Tennessee
United States Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders Milwaukee Wisconsin
United States Yale University New Haven Connecticut
United States Louisiana State University New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center New York New York
United States New Mexico Cancer Care Associates Santa Fe New Mexico
United States Southfield Oncology Institute, Inc. Southfield Michigan
United States Highlands Oncology Group Springdale Arkansas
United States St. Louis Center for Clinical Research St. Louis Missouri
United States SUNY Upstate Medical University Syracuse New York
United States San Diego Cancer Research Institute Vista California

Sponsors (1)

Lead Sponsor Collaborator
Chugai Pharma USA

Country where clinical trial is conducted

United States, 

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