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

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 breast feeding, or planning to become pregnant within 7 months after the end of treatment
• Female subject of childbearing potential is not willing to use 2 highly effective methods of contraception during treatment and for 7 months after the end of treatment
• Subject will not be available for follow-up assessment.
• Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results