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

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharma USA
ClinicalTrials.gov Identifier:
NCT00051779
First received: January 16, 2003
Last updated: June 23, 2005
Last verified: February 2004
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Breast Cancer
Metastasis
Drug: CAL
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chugai Pharma USA:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00051779

  Show 38 Study Locations
Sponsors and Collaborators
Chugai Pharma USA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00051779     History of Changes
Other Study ID Numbers: CAL-03
Study First Received: January 16, 2003
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Chugai Pharma USA:
CAL
Parathyroid hormone-related protein (PTHrP)
Breast Cancer
Bone Metastasis
Hypercalcemia

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Breast Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Skin Diseases
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014