Status:
COMPLETED
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
Lead Sponsor:
Amgen
Conditions:
Breast Cancer
Hypercalcemia of Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 intravenou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00896454
Start Date
November 16 2009
End Date
August 21 2013
Last Update
October 17 2018
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Encinitas, California, United States, 92024
2
Research Site
New Haven, Connecticut, United States, 06520
3
Research Site
Salisbury, Maryland, United States, 21801
4
Research Site
Dearborn, Michigan, United States, 48124