Study Complete
Sponsor ID
20070315
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects with Elevated Serum Calcium
Study Details
The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium = 11.5 mg/dL (2.9 millimoles /L) by day 10.
Protocol Summary
Primary Outcome Measures
Proportion of subjects with a response, defined as corrected serum calcium </= 11.5 mg/dL (2.9 millimoles/L) within 10 days after the first dose of denosumab.
Timeframe: 10 days
Secondary Outcome Measures
Proportion of subjects with a response (ie, corrected serum calcium </= 11.5 mg/dL (2.9 millimoles/L) by visit
Timeframe: 33 months
Proportion of subjects with a complete response (CR) (ie, corrected serum calcium </= 10.8 mg/dL (2.7 millimoles/L) by visit
Timeframe: 33 months
Time to response
Timeframe: 33 months
Time to complete response
Timeframe: 33 months
Duration of response defined as the number of days from the first day of corrected serum calcium </= 11.5 mg/dL (2.9 millimoles/L) to the last day of corrected serum calcium </= 11.5 mg/dL (2.9 millimoles/L)
Timeframe: 33 months
Time to relapse/nonresponse of hypercalcemia of malignancy defined as the number of days from the day of the first dose of denosumab until the last day of corrected serum calcium </= 11.5 mg/dL (2.9 millimoles/L)
Timeframe: 33 months
Changes in corrected serum calcium from baseline
Timeframe: 33 months
Duration of complete response defined as the number of days from the first day of of corrected serum calcium </= 10.8 mg/dL (2.7 millimoles/L) to the last day of corrected serum calcium </= 10.8 mg/dL (2.7 millimoles/L)
Timeframe: 33 months
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
New Haven, CT, United States, 06520
Status
Recruiting
Location
Research Site
Houston, TX, United States, 77030
Status
Recruiting
Location
Research Site
New York, NY, United States, 10065
Status
Recruiting
Location
Research Site
Detroit, MI, United States, 48236
Status
Completed
Location
Research Site
Bronx, NY, United States, 10467
Status
Recruiting
Location
Research Site
Salisbury, MD, United States, 21801
Status
Recruiting
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