A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

CompletadoFase 3ClinicalTrials.gov

ID: NCT00861614Tipo: INTERVENTIONALInicio: 1 de may de 2009Fin estimado: 1 de ago de 2015

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Advanced prostate cancer
At least 1 bone metastasis
Testosterone \< 50 ng/dl
Prior treatment with docetaxel

Criterios de exclusión

Brain metastasis
Autoimmune disease
Known HIV, Hep B, or Hep C infection
More than 2 prior systemic anticancer regimens for prostate cancer
Prior treatment on BMS CA180227 for prostate cancer

Intervenciones

drug

Ipilimumab

5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, Up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure

drug

Placebo

Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Caba, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

La Rioja, La Rioja Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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