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

September 13, 2019 updated by: Amgen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1426ANZ
        • Research Site
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Research Site
    • Córdoba
      • Cordoba, Córdoba, Argentina, X5016KEH
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000PBJ
        • Research Site
  • Austria
      • Wien, Austria, 1090
        • Research Site
  • Belgium
      • Namur, Belgium, 5000
        • Research Site
  • Brazil
      • Rio de Janeiro, Brazil, 20551-030
        • Research Site
      • Rio de Janeiro, Brazil, 22640-000
        • Research Site
      • São Paulo, Brazil, 01209-000
        • Research Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
        • Research Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Research Site
    • São Paulo
      • Santo Andre, São Paulo, Brazil, 09060-650
        • Research Site
      • Sao Paulo, São Paulo, Brazil, 01221-020
        • Research Site
      • Sao Paulo, São Paulo, Brazil, 01509-900
        • Research Site
      • Sao Paulo, São Paulo, Brazil, 04262-000
        • Research Site
      • Sorocaba, São Paulo, Brazil, 18030-200
        • Research Site
  • Czechia
      • Kromeriz, Czechia, 767 55
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Praha 1, Czechia, 110 00
        • Research Site
      • Praha 4, Czechia, 140 00
        • Research Site
      • Praha 4, Czechia, 140 44
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
  • France
      • Saint Cloud, France, 92210
        • Research Site
  • Hungary
      • Debrecen, Hungary, 4012
        • Research Site
      • Dombovar, Hungary, 7200
        • Research Site
  • Israel
      • Haifa, Israel, 31096
        • Research Site
      • Rehovot, Israel, 76100
        • Research Site
      • Tel-Aviv, Israel, 64239
        • Research Site
      • Zerifin, Israel, 70300
        • Research Site
  • Italy
      • Meldola (FC), Italy, 47014
        • Research Site
      • Sora, Italy, 03039
        • Research Site
  • Japan
      • Tokyo, Japan, 135-8550
        • Research Site
    • Hiroshima
      • Kure-shi, Hiroshima, Japan, 737-0023
        • Research Site
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 892-0833
        • Research Site
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan, 259-1193
        • Research Site
    • Osaka
      • Osaka-shi, Osaka, Japan, 540-0006
        • Research Site
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Research Site
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Research Site
  • Latvia
      • Daugavpils, Latvia, 5417
        • Research Site
      • Riga, Latvia, 1079
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Research Site
      • Vilnius, Lithuania, 08660
        • Research Site
  • Panama
      • Panama, Panama
        • Research Site
  • Peru
      • Lima, Peru, LIMA 27
        • Research Site
      • Lima, Peru, Lima 18
        • Research Site
  • Poland
      • Bialystok, Poland, 15-027
        • Research Site
      • Bydgoszcz, Poland, 85-171
        • Research Site
      • Gdansk, Poland, 80-952
        • Research Site
      • Lublin, Poland, 20-954
        • Research Site
      • Poznan, Poland, 61-866
        • Research Site
      • Warszawa, Poland, 00-631
        • Research Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Research Site
      • Chelyabinsk, Russian Federation, 454087
        • Research Site
      • Krasnogorsky District, Russian Federation, 143423
        • Research Site
      • Moscow, Russian Federation, 115478
        • Research Site
      • Obninsk, Russian Federation, 249036
        • Research Site
      • Omsk, Russian Federation, 644013
        • Research Site
      • St Petersburg, Russian Federation, 197089
        • Research Site
  • South Africa
      • Pretoria, South Africa, 0081
        • Research Site
  • Spain
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
    • Andalucía
      • Sevilla, Andalucía, Spain, 41013
        • Research Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46009
        • Research Site
  • Ukraine
      • Lviv, Ukraine, 79031
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Denosumab
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Drug: Denosumab
Administered by subcutaneous injection every 4 weeks (Q4W)
Other Names:
  • Xgeva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2011

Primary Completion (Actual)

August 10, 2018

Study Completion (Actual)

August 10, 2018

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 18, 2011

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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