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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01419717
First received: August 4, 2011
Last updated: April 9, 2014
Last verified: April 2014

August 4, 2011
April 9, 2014
November 2011
December 2014   (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) ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Enrolling by invitation
400
December 2014
December 2014   (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Belgium,   Brazil,   Czech Republic,   France,   Hungary,   Israel,   Italy,   Japan,   Latvia,   Lithuania,   Panama,   Peru,   Poland,   Russian Federation,   South Africa,   Spain,   Ukraine
 
NCT01419717
20110113
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
April 2014

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