Status:
COMPLETED
Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases
Lead Sponsor:
Novartis
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or prostate canc...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Ambulatory patients \>18 years
- Proof of breast cancer or prostate cancer
- Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening
- Negative pregnancy test
- ECOG performance status of 0,1 or 2
- Exclusion criteria:
- Patients with abnormal renal function
- Patients with clinically symptomatic brain metastases
- Known hypersensitivity on zoledronic acid or other bisphosphonates
- Pregnancy or lactation
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00434317
Start Date
August 1 2005
Last Update
February 23 2017
Active Locations (4)
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1
Novartis Investigative Site
Budapest, Hungary
2
Novartis Investigative Site
Pécs, Hungary
3
Novartis Investigative Site
Szeged, Hungary
4
Novartis Investigative Site
Székesfehérvár, Hungary