Overview

This trial is active, not recruiting.

Conditions bone metastases in men with hormone-refractory prostate cancer, bone metastases in subjects with advanced breast cancer
Treatment denosumab
Phase phase 3
Sponsor Amgen
Start date November 2011
End date December 2017
Trial size 129 participants
Trial identifier NCT01419717, 20110113

Summary

This trial will facilitate access of denosumab for subjects with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale, or until another mechanism is identified to provide denosumab to ongoing subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
120 milligrams of denosumab injected subcutaneously every 4 weeks
denosumab Xgeva
120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab is approved and available for sale (expected to be approximately 1 year of treatment per subject)

Primary Outcomes

Measure
Subject incidence of treatment-emergent adverse events
time frame: Study duration (expected to be approximately 1 year per subject)

Secondary Outcomes

Measure
Subject incidence of anti-denosumab antibodies
time frame: Study duration (expected to be approximately 1 year per subject)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study. - Subject or subject's legally acceptable representative has provided informed consent. Exclusion Criteria: - Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment. - Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment. - Subject has known sensitivity to any of the products to be administered during dosing. - Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge. - Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.

Additional Information

Official title Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Amgen.