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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03301857




Registration number
NCT03301857
Ethics application status
Date submitted
29/09/2017
Date registered
4/10/2017
Date last updated
21/10/2019

Titles & IDs
Public title
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Scientific title
Long-term Safety Follow-up of Subjects With Giant Cell Tumor of Bone Treated With Denosumab in Study 20062004
Secondary ID [1] 0 0
2017-001758-32
Secondary ID [2] 0 0
20140114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Giant Cell Tumor of Bone 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Denosumab (Cohort A)

Experimental: Denosumab - Cohort A (subjects who are still being treated with denosumab when 20062004 completes): 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
For subjects undergoing retreatment with denosumab: 120 mg administered SC on Days 1, 8, 15 and 28 then every 4 weeks subsequently.

No Intervention: Safety Follow up - Subjects still receiving treatment will have follow-up study visits in the clinic every 6 months while receiving denosumab (Cohort A).
Subjects who completed denosumab treatment and were in safety follow-up at the conclusion of 20062004 will have follow-up visits performed every 6 months via telephone or in-person clinic visit (Cohort B).


Treatment: Drugs: Denosumab (Cohort A)
Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of adverse events of interest in subjects with GCTB treated with denosumab - Evaluate adverse events of interest in subjects with GCTB treated with denosumab.
Timepoint [1] 0 0
Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
Secondary outcome [1] 0 0
Rate of treatment-emergent adverse events for subjects who are receiving denosumab. - Evaluate treatment-emergent adverse events for subjects who are receiving denosumab.
Timepoint [1] 0 0
Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
Secondary outcome [2] 0 0
Rate of serious adverse events for all subjects. - Evaluate serious adverse events for all subjects.
Timepoint [2] 0 0
Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
Secondary outcome [3] 0 0
Rate of disease progression or recurrence of GCTB for all subjects. - Summarize the rate of disease progression or recurrence of GCTB for all subjects.
Timepoint [3] 0 0
Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.
Secondary outcome [4] 0 0
Rate of GCTB interventions for all subjects. - Summarize the use of GCTB interventions for all subjects.
Timepoint [4] 0 0
Length of Study: through the earliest date of 5 years after signing the ICF, death, withdrawal of consent, or lost to follow-up.

Eligibility
Key inclusion criteria
- Subject was previously enrolled in Study 20062004.

- Subject or subject's legally acceptable representative has provided informed
consent/assent prior to initiation of any study-specific activities/procedures.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject likely to not be available to complete all protocol-required study visits or
procedures, and/or to comply with all required study procedures to the best of the
subject and investigator's knowledge.

- Females of childbearing potential on denosumab and not willing to continue to use 1
highly effective method of contraception during treatment and for 5 months after the
end of treatment

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment postcode(s) [1] 0 0
2250 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
France
State/province [6] 0 0
Lyon CEDEX 08
Country [7] 0 0
France
State/province [7] 0 0
Villejuif
Country [8] 0 0
Italy
State/province [8] 0 0
Bologna
Country [9] 0 0
Poland
State/province [9] 0 0
Warszawa
Country [10] 0 0
Spain
State/province [10] 0 0
Baleares
Country [11] 0 0
Sweden
State/province [11] 0 0
Lund
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Birmingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study 20140114 will continue to follow subjects with GCTB who were treated in Study 20062004
and remained on the study at the completion of Study 20062004 for an additional 5 years on
long-term safety follow up.
Trial website
https://clinicaltrials.gov/show/NCT03301857
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications