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.

Amgen Inc0 个研究点目标入组 33 人开始时间: 2009年9月1日最近更新: 2012年9月3日

适应症

试验速览

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•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

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