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 orcytologically confirmed cancer and a corrected serum calcium (CSC) > 12.5 mg/dL (3.1millimoles /L) at screening by local laboratory

• Last IV bisphosphonate treatment must be >/= to 7 days and </= to 30 days before thescreening 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 granulomatousdisease

• Receiving dialysis for renal failure

• Treatment with thiazides, calcitonin, mithramycin, or gallium nitrate within theirwindow of expected therapeutic effect (as determined by the physician) prior to thedate 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) inanother 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 7months after the end of treatment

• Female subject of childbearing potential is not willing to use 2 highly effectivemethods 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, mightprevent the subject from completing the study or interfere with the interpretation ofthe study results