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

Completed · Phase 2

Conditions studied: Breast Cancer, Hypercalcemia of Malignancy, Colon Cancer, Endocrine Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Lymphoma, Metastatic Cancer, Multiple Myeloma, Parathyroid Neoplasms, Renal Cancer, Thyroid Cancer, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Non-Small Cell Lung Cancer

In brief

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 \</= 11.5 mg/dL (2.9 millimoles /L) by day 10.

Key facts

Study ID: NCT00896454
Run by: Amgen
People needed: 33
Starts: 2009-11-16
Expected to finish: 2013-08-21
Last updated by the study team: 2018-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Encinitas, California, United States
Research Site — New Haven, Connecticut, United States
Research Site — Salisbury, Maryland, United States
Research Site — Dearborn, Michigan, United States
Research Site — Detroit, Michigan, United States
Research Site — Omaha, Nebraska, United States
Research Site — New York, New York, United States
Research Site — Syracuse, New York, United States
Research Site — The Bronx, New York, United States
Research Site — Durham, North Carolina, United States
Research Site — Goldsboro, North Carolina, United States
Research Site — Houston, Texas, United States
Research Site — Québec, Quebec, Canada
Research Site — Limoges, France
Research Site — Montpellier, France
Research Site — Nantes, France
Research Site — Villejuif, France
Research Site — Bologna, Italy
Research Site — Florence, Italy
Research Site — Milan, Italy
Research Site — Padova, Italy
Research Site — Roma, Italy
Research Site — Warsaw, Poland

Full record on ClinicalTrials.gov

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