Estudio de discontinuación aleatoria de brivanib alaninate (BMS-582664) versus placebo en sujetos con tumores avanzados

CompletadoFase 2ClinicalTrials.gov

ID: NCT00633789Tipo: INTERVENTIONALInicio: 1 de jun de 2008Fin estimado: 1 de dic de 2012

Resumen

El propósito de este estudio es determinar si los pacientes con tumores gástrico/esofágico, pulmonar, pancreático, de vejiga y sarcoma obtienen beneficio del tratamiento con brivanib. Los pacientes en quienes el beneficio es claramente evidente continúan el tratamiento. Aquellos en quienes no está claro serán aleatorizados para continuar o retirar el tratamiento, con el fin de determinar si dicho beneficio está relacionado con brivanib.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Life expectancy at least 3 months
Diagnosis of a solid tumor which is unresectable in which no approved effective therapy exists or for subjects who are intolerable to such therapy. The initial enrollment will focus on non-small cell lung, gastric/esophageal adenocarcinoma, soft tissue sarcoma, transitional cell carcinoma, and pancreatic cancer including ampulla of Vater tumors
Adequate tumor sample
Adequate recovery (baseline or Grade 1) from recent therapy. At least 1 week must have elapsed from the time of a minor surgery, and at least 8 weeks for major surgery or radiation therapy

Criterios de exclusión

Subjects with known brain metastasis.
Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI
Medical History and Concurrent Diseases:
History of thrombo-embolic disease within the last six months requiring therapeutic anticoagulation
Subjects with history of poor wound healing or non healing ulcers
Uncontrolled or significant cardiovascular disease
Allergies and Adverse Drug Reactions:
History of allergy to brivanib its drug class, or related compounds
Prohibited Treatments and/or Therapies:
Exposure to any investigational drug within 4 weeks of enrollment
Other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiotherapy, standard or investigational. Subjects may continue to receive hormone replacement therapy
Prior exposure to brivanib

Intervenciones

drug

brivanib

Tablets, Oral, 800 mg, once daily, until progression

drug

Placebo

Tablets, Oral, 0 mg, once daily, until progression

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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