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Study Complete
Sponsor ID
20110113

Open-Label Access Protocol of Denosumab for Subjects with Advanced Cancer

Sponsor ID
20110113
Clinicaltrials.gov ID
NCT01419717
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
129
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of treatment-emergent adverse events

Timeframe: Study duration (expected to be approximately 1 year per subject)

Secondary Outcome Measures

Subject incidence of anti-denosumab antibodies

Timeframe: Study duration (expected to be approximately 1 year per subject)

Locations

Location
Status
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Location
Research Site
Krasnogorsky District, Russian Federation, 143423
Status
Completed
Location
Research Site
St Petersburg, Russian Federation, 197089
Status
Completed
Location
Research Site
Praha 5, Czech Republic, 150 06
Status
Completed
Location
Research Site
Praha 4, Czech Republic, 140 44
Status
Completed
Location
Research Site
Debrecen, Hungary, 4012
Status
Completed
Location
Research Site
Gdansk, Poland, 80-952
Status
Completed
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Study Info
Age
18+ years
Condition
  • Prostate Cancer
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  • Breast Cancer
    • Sex
    All
    Trial Dates
    Nov 2011 - Aug 2018
    Inclusion and Exclusion 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.