CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0595 (clinicaltrials.gov NCT No: NCT00896454)
Title: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
Principal Investigator:Mimi Hu
Treatment Agent:Denosumab
Study Status:Terminated
Study Description:The goal of this clinical research study is learn if denosumab can help to
control hypercalcemia in patients with cancer. The safety of this drug will
also be studied.

Hide details for General InformationGeneral Information

Disease Group:Advanced Cancers; Endocrine; Laboratory
Phase of Study:Phase II
Treatment Agents:Denosumab
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:As needed
Supported By:Amgen Inc.
Return Visit:Subjects will have study visits on study days 1, 2, 4, 8, 10, 15, 19, 23, 29,
weekly up to study day 57, and every month until end of study.
Home Care:Available through a contracted vendor funded by the sponsor for study-related
blood draws, assessment of signs/symptoms, and review of concomitant
medications.


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Mimi Hu
Dept:Endocrine Neoplasia & Hormonal Disorders
For Clinical Trial Enrollment:713-792-2841
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults