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 = 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