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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01419717Tipo: INTERVENTIONALInicio: 22 de nov de 2011Fin estimado: 10 de ago de 2018

Oncología Obstetricia y Ginecología Urología

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Denosumab

Administered by subcutaneous injection every 4 weeks (Q4W)

Ubicaciones

Research Site

Capital Federal, Buenos Aires, Argentina

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalAmgen

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