Clinical trial NCT01419717: Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Official title: Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Bone Metastases in Subjects With Advanced Breast Cancer
Keywords: cancer
bone metastases
breast cancer
prostate cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-08-18
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 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 outcomes:
measure: Number of Participants With Anti-denosumab Binding Antibodies
timeFrame: Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Research Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Research Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Research Site
state: Córdoba
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Wien
country: Austria
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Research Site
state: Rio Grande Do Sul
city: Santo Andre
country: Brazil
facility: Research Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Research Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Research Site
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Research Site
state: São Paulo
city: Sorocaba
country: Brazil
facility: Research Site
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Kromeriz
country: Czechia
facility: Research Site
city: Olomouc
country: Czechia
facility: Research Site
city: Praha 1
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Praha 5
country: Czechia
facility: Research Site
city: Saint Cloud
country: France
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Dombovar
country: Hungary
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Tel-Aviv
country: Israel
facility: Research Site
city: Zerifin
country: Israel
facility: Research Site
city: Meldola (FC)
country: Italy
facility: Research Site
city: Sora
country: Italy
facility: Research Site
city: Kure-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Kagoshima-shi
country: Japan
facility: Research Site
state: Kagoshima
city: Isehara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Research Site
state: Saitama
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Tokyo
country: Japan
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Panama
country: Panama
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Krasnogorsky District
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
state: Andalucía
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: