Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
- Conditions
- Hypercalcemia of malignancy (HCM)MedDRA version: 15.0Level: LLTClassification code 10020588Term: Hypercalcemia of malignancySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-009756-21-PL
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
• Hypercalcemia of Malignancy (HCM) as defined as documented histologically or cytologically confirmed cancer and a CSC > 12.5 mg/dL (3.1 mmol/L) at screening by local laboratory
• Last IV bisphosphonate treatment must be = 7 days and = 30 days before the screening CSC
• 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 ULN
- serum total bilirubin = 2 x ULN
• Before any study-specific procedure is performed, the appropriate written informed consent must be obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the potential for denosumab to treat HCM that does not respond to recent treatment with Intravenous (IV) bisphosphonates by lowering corrected serum calcium (CSC) = 11.5 mg/dL (2.9 mmol/L) by study day 10.;Secondary Objective: • To determine the duration of the treatment effect<br>• To determine the time to response<br>• To determine the time to relapse/nonresponse<br>• Changes in CSC level from baseline<br>• To determine the safety of denosumab in this subject population;Primary end point(s): Proportion of subjects with a response, defined as CSC = 11.5 mg/dL (2.9 mmol/L), within 10 days after the first dose of denosumab;Timepoint(s) of evaluation of this end point: Day 10
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Proportion of subjects with a response (ie, CSC =11.5 mg/dL [2.9 mmol/L]) by visit<br>• Proportion of subjects with a complete response (CR) (ie, CSC =10.8 mg/dL [2.7 mmol/L]) by visit<br>• Time to response<br>• Time to CR<br>• Duration of response defined as the number of days from the first day of CSC = 11.5 mg/dL (2.9 mmol/L) to the last day of CSC =11.5 mg/dL (2.9 mmol/L)<br>• Duration of CR defined as the number of days from the first day of CSC = 10.8 mg/dL (2.7 mmol/L) to the last day of CSC =10.8 mg/dL (2.7 mmol/L)<br>• Time to relapse/nonresponse of HCM <br>• Changes in CSC from baseline<br>• Type, frequency, and severity of adverse events<br>• Changes in laboratory values;Timepoint(s) of evaluation of this end point: • Efficacy endpoints: Months 3, 9 and 15<br>• Safety endpoints: Months 3 and 9