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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
  Purpose
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.

Condition Intervention Phase
Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer Drug: denosumab Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of treatment-emergent adverse events [ Time Frame: Study duration (expected to be approximately 1 year per subject) ]

Secondary Outcome Measures:
  • Subject incidence of anti-denosumab antibodies [ Time Frame: Study duration (expected to be approximately 1 year per subject) ]

Enrollment: 129
Actual Study Start Date: November 22, 2011
Estimated Study Completion Date: December 27, 2017
Estimated Primary Completion Date: December 27, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: denosumab
120 milligrams of denosumab injected subcutaneously every 4 weeks
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419717


  Hide Study Locations
Locations
Argentina
Research Site
Capital Federal, Buenos Aires, Argentina, C1426ANZ
Research Site
Quilmes, Buenos Aires, Argentina, B1878GEG
Research Site
Cordoba, Córdoba, Argentina, X5016KEH
Research Site
Rosario, Santa Fe, Argentina, S2000PBJ
Austria
Research Site
Wien, Austria, 1090
Belgium
Research Site
Namur, Belgium, 5000
Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Research Site
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Research Site
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
Rio de Janeiro, Brazil, 20551-030
Research Site
Rio de Janeiro, Brazil, 22640-000
Research Site
São Paulo, Brazil, 01209-000
Czechia
Research Site
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
France
Research Site
Saint Cloud, France, 92210
Hungary
Research Site
Debrecen, Hungary, 4012
Research Site
Dombovar, Hungary, 7200
Israel
Research Site
Haifa, Israel, 31096
Research Site
Rehovot, Israel, 76100
Research Site
Tel-Aviv, Israel, 64239
Research Site
Zerifin, Israel, 70300
Italy
Research Site
Meldola (FC), Italy, 47014
Research Site
Sora, Italy, 03039
Japan
Research Site
Kure-shi, Hiroshima, Japan, 737-0023
Research Site
Kagoshima-shi, Kagoshima, Japan, 892-0833
Research Site
Isehara-shi, Kanagawa, Japan, 259-1193
Research Site
Osaka-shi, Osaka, Japan, 540-0006
Research Site
Kitaadachi-gun, Saitama, Japan, 362-0806
Research Site
Chuo-ku, Tokyo, Japan, 104-0045
Research Site
Tokyo, Japan, 135-8550
Latvia
Research Site
Daugavpils, Latvia, 5417
Research Site
Riga, Latvia, 1079
Lithuania
Research Site
Kaunas, Lithuania, 50009
Research Site
Vilnius, Lithuania, 08660
Panama
Research Site
Panama, Panama
Peru
Research Site
Lima, Peru, Lima 18
Research Site
Lima, Peru, Lima 27
Poland
Research Site
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
Russian Federation
Research Site
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
South Africa
Research Site
Pretoria, South Africa, 0081
Spain
Research Site
Sevilla, Andalucía, Spain, 41013
Research Site
Valencia, Comunidad Valenciana, Spain, 46009
Research Site
Madrid, Spain, 28034
Research Site
Madrid, Spain, 28040
Ukraine
Research Site
Lviv, Ukraine, 79031
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01419717     History of Changes
Other Study ID Numbers: 20110113
First Submitted: August 4, 2011
First Posted: August 18, 2011
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by Amgen:
cancer
bone metastases
breast cancer
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs