NCT00478270WithdrawnPhase 2
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Hoffmann-La Roche
- Primary Endpoint
- Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Experimental
Intervention: ibandronate [Bondronat] (Drug)
Outcomes
Primary Outcomes
Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption
Time Frame: Days 5 - 7
Secondary Outcomes
- Analgesic consumption(Day 7)
- Mean worst pain score over first 7 days(Day 7)
- Karnofsky index(Day 7)
- AEs, laboratory parameters(Throughout study)
Investigators
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