Clinical trial NCT00950911: Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
Official title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
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
Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Keywords: Bone metastases
Hormone-refractory prostate cancer
Multiple myeloma
Denosumab
Breast cancer
20050103
20050136
20050244
Advanced cancer
Tumor
Prostate cancer
Zoledronic acid
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-08-03
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.


Eligibility criteria: Inclusion Criteria:

* Subjects currently enrolled in study 20050103, 20050136, or 20050244
* Subjects must sign the informed consent before any study specific procedures are performed

Exclusion Criteria:

* Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study
* Currently receiving any unapproved investigational product other than denosumab
* Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
* Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment
* Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment
* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures

Primary outcomes:
measure: Number of Participants Survived
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jindrichuv Hradec
country: Czech Republic
facility: Research Site
city: Kromeriz
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Praha 1
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Chichester
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: