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



Status:Completed
Conditions:Breast Cancer, Lung Cancer, Colorectal Cancer, Cancer, Cancer, Blood Cancer, Lymphoma, Hematology, Kidney Cancer, Thyroid Cancer
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:November 16, 2009
End Date:August 21, 2013

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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

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 millimoles /L) by day 10.


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
We found this trial at
13
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New Haven, CT
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Durham, NC
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Encinitas, CA
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Goldsboro, North Carolina 27534
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Houston, TX
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New York, NY
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Omaha, NE
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Québec,
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Salisbury, MD
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Syracuse, NY
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