Status:
COMPLETED
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Lead Sponsor:
Amgen
Conditions:
Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Bone Metastases in Subjects With Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
November 22 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2018
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01419717
Start Date
November 22 2011
End Date
August 10 2018
Last Update
September 24 2019
Active Locations (64)
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1
Research Site
Capital Federal, Buenos Aires, Argentina, C1426ANZ
2
Research Site
Quilmes, Buenos Aires, Argentina, B1878GEG
3
Research Site
Córdoba, Córdoba Province, Argentina, X5016KEH
4
Research Site
Rosario, Santa Fe Province, Argentina, S2000PBJ