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 - ND

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

Related Trials

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

Amgen Inc

Updated 9/3/2012