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Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01419717
First Posted: August 18, 2011
Last Update Posted: May 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
August 4, 2011
August 18, 2011
May 31, 2017
November 22, 2011
December 27, 2017   (Final data collection date for primary outcome measure)
Subject incidence of treatment-emergent adverse events [ Time Frame: Study duration (expected to be approximately 1 year per subject) ]
Same as current
Complete list of historical versions of study NCT01419717 on ClinicalTrials.gov Archive Site
Subject incidence of anti-denosumab antibodies [ Time Frame: Study duration (expected to be approximately 1 year per subject) ]
Same as current
Not Provided
Not Provided
 
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bone Metastases in Men With Hormone-Refractory Prostate Cancer
  • Bone Metastases in Subjects With Advanced Breast Cancer
Drug: denosumab
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)
Other Name: Xgeva
Experimental: denosumab
120 milligrams of denosumab injected subcutaneously every 4 weeks
Intervention: Drug: denosumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
129
December 27, 2017
December 27, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Belgium,   Brazil,   Czechia,   France,   Hungary,   Israel,   Italy,   Japan,   Latvia,   Lithuania,   Panama,   Peru,   Poland,   Russian Federation,   South Africa,   Spain,   Ukraine
Czech Republic,   India
 
NCT01419717
20110113
No
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP