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.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 33

Inclusion Criteria

• 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Evidence of hyperparathyroidism, hyperthyroidism, adrenal insufficiency, vitamin D intoxication, milk alkali syndrome, sarcoidosis, or other granulomatous disease
• Receiving dialysis for renal failure
• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
• Active dental or jaw condition which requires oral surgery
• Non-healed dental/oral surgery
• Planned invasive dental procedure over the course of the study
• Prior administration of denosumab
• Treatment with thiazides, calcitonin, mithramycin, and gallium nitrate within 7 days 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 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
• Subject (male or female) is not willing to use 2 highly effective methods of contraception during treatment and for 7 months (female) or 10 months (male) after the end of treatment
• Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 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

Secondary Outcome Measures

Name	Time	Method

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