A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT00474786Tipo: INTERVENTIONALInicio: 1 de sept de 2007Fin estimado: 1 de ene de 2013

Traducción no disponible, mostrando original

Resumen

This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.
More criteria apply

Criterios de exclusión

Metastatic CNS from RCC.
Subjects who discontinued Sutent therapy due specifically to intolerance.
Prior systemic therapy for mRCC other than sunitinib.
Active ketonuria, secondary to poorly controlled diabetes mellitus
More criteria apply

Intervenciones

drug

Sorafenib

Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).

drug

temsirolimus (Torisel)

Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Buenos Aires, Argentina

Pfizer Investigational Site

Rosario, Santa Fe Province, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Nueva Cordoba, Argentina

Pfizer Investigational Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalPfizer

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