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

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.
 
ClinicalTrials.gov Identifier: NCT01419717
Recruitment Status : Completed
First Posted : August 18, 2011
Results First Posted : September 9, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE August 4, 2011
First Posted Date  ICMJE August 18, 2011
Results First Submitted Date  ICMJE August 1, 2019
Results First Posted Date  ICMJE September 9, 2019
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE November 22, 2011
Actual Primary Completion Date August 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
Number of Participants With Adverse Events [ Time Frame: From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months. ]
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
Subject incidence of treatment-emergent adverse events [ Time Frame: Study duration (expected to be approximately 1 year per subject) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
Number of Participants With Anti-denosumab Binding Antibodies [ Time Frame: Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months. ]
A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2011)
Subject incidence of anti-denosumab antibodies [ Time Frame: Study duration (expected to be approximately 1 year per subject) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Official Title  ICMJE Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Brief Summary This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bone Metastases in Men With Hormone-Refractory Prostate Cancer
  • Bone Metastases in Subjects With Advanced Breast Cancer
Intervention  ICMJE Drug: Denosumab
Administered by subcutaneous injection every 4 weeks (Q4W)
Other Name: Xgeva
Study Arms  ICMJE Experimental: Denosumab
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Intervention: Drug: Denosumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2015)
129
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2011)
400
Actual Study Completion Date  ICMJE August 10, 2018
Actual Primary Completion Date August 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Brazil,   Czechia,   France,   Hungary,   Israel,   Italy,   Japan,   Latvia,   Lithuania,   Panama,   Peru,   Poland,   Russian Federation,   South Africa,   Spain,   Ukraine
Removed Location Countries Czech Republic,   India
 
Administrative Information
NCT Number  ICMJE NCT01419717
Other Study ID Numbers  ICMJE 20110113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date September 2019

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