Estudio Multicéntrico, de Etiqueta Abierta para Evaluar la Seguridad de RO5185426 (Vemurafenib) en Pacientes con Melanoma Metastásico

CompletadoFase 3ClinicalTrials.gov

ID: NCT01307397Tipo: INTERVENTIONALInicio: 1 de mar de 2011Fin estimado: 24 de feb de 2016

Resumen

Este estudio multicéntrico evalúa la seguridad y eficacia de vemurafenib en participantes con melanoma metastásico en estadio IIIC o IV (American Joint Committee on Cancer [AJCC]), con mutación BRAF V600 positiva, irresecable quirúrgicamente.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Participants with Histologically confirmed metastatic melanoma (surgically incurable and unresectable Stage IIIC or Stage IV; AJCC) with BRAF V 600 mutation determined by Cobas 4800 BRAF Mutation Test. Unresectable Stage IIIC disease must have had confirmation from a surgical oncologist
Participants with either measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1
Participants may or may not have received prior systemic therapy for metastatic melanoma
Eastern Cooperative Oncology Group (ECOG) performance status between 0 to 2
Adequate hematologic, renal and liver function

Criterios de exclusión

Evidence of symptomatic central nervous system (CNS) lesions, use of steroids or anti-seizure medications for treatment of brain metastases prior to the first administration of vemurafenib
Previous malignancy (other than melanoma) within the past 2 years, except for treated and controlled basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
Concurrent administration of any anti-cancer therapies other than those administered in the study
Clinically significant cardiovascular disease or event within the 6 months prior to first administration of study drug
Refractory nausea or vomiting, external biliary shunt, or significant bowel resection that would preclude adequate absorption

Intervenciones

drug

Vemurafenib

Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.

Ubicaciones

Hospital Britanico; Oncologia

Buenos Aires, Argentina

Fundación CIDEA

Buenos Aires, Argentina

Inst. Alexander Fleming; Oncologia

Buenos Aires, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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