Trials / Completed
CompletedNCT00896454
Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | denosumab | 120 mg subcutaneously (SC) every 4 weeks with a loading dose of 120 mg SC on study days 8 and 15. |
Timeline
- Start date
- 2009-11-16
- Primary completion
- 2012-09-13
- Completion
- 2013-08-21
- First posted
- 2009-05-11
- Last updated
- 2018-10-17
- Results posted
- 2015-01-01
Locations
24 sites across 5 countries: United States, Canada, France, Italy, Poland
Source: ClinicalTrials.gov record NCT00896454. Inclusion in this directory is not an endorsement.