Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
NCT ID: NCT01419717
Last Updated: 2019-09-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
129 participants
INTERVENTIONAL
2011-11-22
2018-08-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Denosumab
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
Denosumab
Administered by subcutaneous injection every 4 weeks (Q4W)
Interventions
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Denosumab
Administered by subcutaneous injection every 4 weeks (Q4W)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject or subject's legally acceptable representative has provided informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Capital Federal, Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
Research Site
Córdoba, Córdoba Province, Argentina
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
Vienna, , Austria
Research Site
Namur, , Belgium
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Santo André, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Sorocaba, São Paulo, Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
Rio de Janeiro, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Kroměříž, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Saint-Cloud, , France
Research Site
Debrecen, , Hungary
Research Site
Dombóvár, , Hungary
Research Site
Haifa, , Israel
Research Site
Rehovot, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Ẕerifin, , Israel
Research Site
Meldola (FC), , Italy
Research Site
Sora, , Italy
Research Site
Kure-shi, Hiroshima, Japan
Research Site
Kagoshima, Kagoshima-ken, Japan
Research Site
Isehara-shi, Kanagawa, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Kitaadachi-gun, Saitama, Japan
Research Site
Chuo-ku, Tokyo, Japan
Research Site
Tokyo, , Japan
Research Site
Daugavpils, , Latvia
Research Site
Riga, , Latvia
Research Site
Kaunas, , Lithuania
Research Site
Vilnius, , Lithuania
Research Site
Panama City, , Panama
Research Site
Lima, , Peru
Research Site
Lima, , Peru
Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Gdansk, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Warsaw, , Poland
Research Site
Arkhangelsk, , Russia
Research Site
Chelyabinsk, , Russia
Research Site
Krasnogorsky District, , Russia
Research Site
Moscow, , Russia
Research Site
Obninsk, , Russia
Research Site
Omsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Pretoria, , South Africa
Research Site
Seville, Andalusia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Lviv, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20110113
Identifier Type: -
Identifier Source: org_study_id
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