A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00073307Tipo: INTERVENTIONALInicio: 1 de nov de 2003Fin estimado: 1 de abr de 2010

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Descripción detallada

Overall Survival (OS), Patient-reported outcome (PRO)

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
Patients who have adequate coagulation, liver and kidney functions

Criterios de exclusión

Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated \> 2 years prior to entry
Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Patients with a history or presence of metastatic brain or meningeal tumors
Patients with seizure disorder requiring medication (such as anti-epileptics)
History of organ allograft or bone marrow transplant of stem cell rescue
Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
Patients who have three or more of the following:
ECOG performance status greater than or equal to 2,
Abnormally high lactate dehydrogenase,
Abnormally high serum hemoglobin,
Abnormally high corrected serum calcium,
Absence of prior nephrectomy
Excluded therapies and medications, previous and concomitant:
Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
Significant surgery with 4 weeks of start of study
Investigational drug therapy during or within 30 days
Concomitant treatment with rifampin or St. John's Wort
Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors

Intervenciones

drug

Sorafenib (Nexavar, BAY43-9006)

Multi Kinase Inhibitor

drug

Placebo

Ubicaciones

Rosario, Santa Fe Province, Argentina

Santa Fé, Santa Fe Province, Argentina

Capital Federal-Buenos Aires, Argentina

Mendoza, Argentina

Patrocinadores

PrincipalBayer

ColaboradorAmgen

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