Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 17, 2018 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Amgen
- Interventions being studied
- Drug: denosumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Research SiteEncinitas, California
- Research SiteNew Haven, Connecticut
- Research SiteSalisbury, Maryland
- Research SiteDearborn, Michigan
- Research SiteDetroit, Michigan
- Research SiteOmaha, Nebraska
- Research SiteNew York, New York
- Research SiteSyracuse, New York
- Research SiteThe Bronx, New York
- Research SiteDurham, North Carolina
- Research SiteGoldsboro, North Carolina
- Research SiteHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 17, 2018. Always confirm current availability with the study team.