A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain;; Bone Neoplasms;; Neoplasm Metastasis
Intervention: ibandronate [Bondronat] (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Summary
This single arm study will assess the efficacy of loading doses of intravenous Bondronat in
reducing pain in patients with breast cancer and metastatic bone disease experiencing
moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat
on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target
sample size is <100 individuals.
Clinical Details
Official title: An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Secondary outcome: Mean worst pain score over first 7 daysAnalgesic consumption Karnofsky index AEs, laboratory parameters
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult patients, >=18 years of age;
- breast cancer;
- bone metastases;
- mean worst pain score >=4 during 3 day baseline period;
- stable dose of analgesics over a 3 day baseline period;
- adequate renal function.
Exclusion Criteria:
- bisphosphonate treatment within 3 weeks of study enrollment;
- a change in antineoplastic treatment within 6 weeks of study enrollment;
- bone radiation within 2 weeks of study enrollment;
- active infection.
Locations and Contacts
Alexandroupolis, Greece
Athens, Greece
Haidari, Greece
Patras, Greece
Piraeus, Greece
Thessaloniki, Greece
Additional Information
Ending date: January 2008
Last updated: March 19, 2008
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