Breast Cancer Clinical Trial
Official title:
A Stratified, Randomized, Open-label, Multi-center Comparative 2-arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)
Verified date | September 2014 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Male or female between 18-75 years of age - Multiple myeloma or breast cancer with bone involvement - Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received. Exclusion Criteria: - Current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery - Active or uncontrolled infection, liver, or renal disease - History of treatment with intravenous bisphosphonates - Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease) Other protocol-defined inclusion/exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont Fletcher Allen Health Care | Burlington | Vermont |
United States | Rocky Mountain Cancer Centers RMCC | Greenwood Village | Colorado |
United States | Norwalk Hospital | Norwalk | Connecticut |
United States | Hillman Cancer Center | Pittsburgh | Pennsylvania |
United States | Virginia Cancer Institute Virginia Cancer Center | Richmond | Virginia |
United States | Huntsman Cancer Institute Univ. of Utah | Salt Lake City | Utah |
United States | Oncotherapeutics | West Hollywood | California |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17 | every four (4) weeks | ||
Primary | Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13 | every four (4) weeks | ||
Secondary | Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits. | every four (4) weeks | ||
Secondary | Efficacy outcomes will be measured throughout the study by number and time to skeletal related events (determined by bone surveys and bone scans) as well as the measurement of pain and analgesic scores. | bone survey = every 12 weeks; bone scan = every 24 weeks; pain & analgesic scores = weekly prior to visit 8 (inclusive), every 4 weeks after visit 8 |
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