At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 33 enrolled
Drug / intervention
denosumabdrug
Likely dose
denosumab 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating denosumab for Breast Cancer and 15 related conditions. Completed, enrolled 33 participants across 24 sites in 5 countries.
Detailed 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 intravenous bisphosphonates by lowering corrected serum calcium \</= 11.5 mg/dL (2.9 millimoles /L) by day 10.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Hypercalcemia of Malignancy, Colon Cancer, Endocrine Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Lymphoma, Metastatic Cancer, Multiple Myeloma, Parathyroid Neoplasms, Renal Cancer, Thyroid Cancer, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Non-Small Cell Lung Cancer
CountriesCanada, France, Italy, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 2009
Enrollment StartNov 2009
Primary CompletionSep 2012
Study CompletionAug 2013
TodayJul 2026
First PostedMay 11, 2009
Enrollment StartNov 16, 2009
Primary CompletionSep 13, 2012
Study CompletionAug 21, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.1 years ago
Interventions
denosumabdrug
120 mg subcutaneously (SC) every 4 weeks with a loading dose of 120 mg SC on study days 8 and 15.