Study Complete
Sponsor ID
20070315

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects with Elevated Serum Calcium

Sponsor ID
20070315
Clinicaltrials.gov ID
NCT00896454
EUCTIS ID
N/A
EudraCT ID
N/A

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

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
33
Additional Study Details

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
Status
Contact Us
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
Showing {first} - {last} of {total} Results