Trial information
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.
Status: Terminated
Protocol number: ML20247
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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.
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. Target sample size is 52.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Pain; Bone Neoplasms; Neoplasm Metastasis
Intervention type: Drug
Intervention name: ibandronate [Bondronat]
Primary outcome: 1. Pain response (20% decrease in mean pain score compared to baseline, and <=50% increase in mean analgesic consumption Time frame: Days 5 - 7
Key secondary outcomes: 1. Mean worst pain score over first 7 days Time frame: Day 7
2. Analgesic consumption Time frame: Day 7
3. Karnofsky index Time frame: Day 7
4. AEs, laboratory parameters Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/17/2007
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Greece
- Alexandroupolis
- Athens
- Haidari
- Patras
- Piraeus
- Thessaloniki
