Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Seru… (NCT00896454) | Clinical Trial Compass
CompletedPhase 2
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
United States33 participantsStarted 2009-11-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a corrected serum calcium (CSC) \> 12.5 mg/dL (3.1 millimoles /L) at screening by local laboratory
* Last IV bisphosphonate treatment must be \>/= to 7 days and \</= to 30 days before the screening corrected serum calcium
* Adults (\>/=18 years)
* Adequate organ function as defined by the following criteria:
* serum aspartate aminotransferase (AST) \</= 5 x upper limit of normal (ULN)
* serum alanine aminotransferase (ALT) \</= 5 x upper limit of normal
* serum total bilirubin \</= 2 x upper limit of normal
Exclusion Criteria:
* Evidence of benign hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
* Receiving dialysis for renal failure
* Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within their window of expected therapeutic effect (as determined by the physician) prior to the date of the screening CSC
* Treatment with cinacalcet within 4 weeks prior to the date of the screening CSC
* Thirty days or less since receiving an investigational product (other than denosumab) or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical study
* Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products)
* Female subject is pregnant or br…
What they're measuring
1
Percentage of Participants With a Response Within 10 Days of First Dose of Denosumab