A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium Despite Recent Treatment With IV Bisphosphonates

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 screening corrected serum calcium

- Adults (>/=18 years)

- Adequate organ function as defined by the following criteria:

- serum aspartate aminotransferase (AST)
- serum alanine aminotransferase (ALT)
- serum total bilirubin
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