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

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:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Prostate Cancer

Drug Information available for: Denosumab

U.S. FDA Resources

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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Subject incidence of anti-denosumab antibodies [ Time Frame: Study duration (expected to be approximately 1 year per subject) ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	November 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419717

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Locations

Argentina
Research Site
Capital Federal, Buenos Aires, Argentina, C1426ANZ
Research Site
Quilmes, Buenos Aires, Argentina, B1878GEG
Research Site
Cordoba, CÃ³rdoba, Argentina, X5006HBF
Research Site
Cordoba, CÃ³rdoba, Argentina, X5016KEH
Austria
Research Site
Wien, Austria, 1090
Belgium
Research Site
Namur, Belgium, 5000
Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Research Site
Santo Andre, SÃ£o Paulo, Brazil, 09060-650
Research Site
Sao Paulo, SÃ£o Paulo, Brazil, 01509-900
Research Site
Sao Paulo, SÃ£o Paulo, Brazil, 04262-000
Research Site
Sorocaba, SÃ£o Paulo, Brazil, 18030-200
Research Site
Rio de Janeiro, Brazil, 22640-000
Research Site
Rio de Janeiro, Brazil, 20551-030
Research Site
SÃ£o Paulo, Brazil, 01209-000
Czech Republic
Research Site
Kromeriz, Czech Republic, 767 55
Research Site
Olomouc, Czech Republic, 775 20
Research Site
Praha 1, Czech Republic, 110 00
Research Site
Praha 4, Czech Republic, 140 44
Research Site
Praha 4, Czech Republic, 140 00
Research Site
Praha 5, Czech Republic, 150 06
France
Research Site
Le Mans, France, 72000
Research Site
Paris Cedex 14, France, 75674
Research Site
Reims, France, 51100
Research Site
Saint Cloud, France, 92210
Hungary
Research Site
Debrecen, Hungary, 4012
Research Site
Dombovar, Hungary, 7200
India
Research Site
Jaipur, Rajasthan, India, 302 013
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, AndalucÃ-a, Spain, 41013
Research Site
Valencia, Comunidad Valenciana, Spain, 46009
Research Site
Madrid, Spain, 28040
Research Site
Madrid, Spain, 28034
Ukraine
Research Site
Lviv, Ukraine, 79031

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01419717 History of Changes
Other Study ID Numbers:	20110113
Study First Received:	August 4, 2011
Last Updated:	May 6, 2013
Health Authority:	Australia: Therapeutic Goods Administration Brazil: ANVISA (Agência Nacional de Vigilância Sanitária) Brazil: Ministry of Health Chile: Health Ministry European Union: European Medicines Agency India: Central India Medical Research Ethics Committee Israel: Ministry of Health Panama: Ministry of Health Peru: Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) Peru: INS (Instituto Nacional de Salud) Peru: Ministry of Health Russia: National Ethic Committee South Africa: Medicines Control Council Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre) United Kingdom: Medicines and Healthcare Products Regulatory Agency Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica) Argentina: Ministry of Health

Keywords provided by Amgen:

cancer
bone metastases
breast cancer
prostate cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Prostatic Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Neoplastic Processes
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013