Spots Global Cancer Trial Database for Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer
Official Title: An Open-Label, Randomized, Multicenter, Phase 3 Study to Determine the Safety, Tolerability, and Tumor Response of Oraxol and Its Comparability to IV Taxol or Generic IV Paclitaxel in Subjects With Metastatic Breast Cancer
Study ID: NCT02594371
Conditions
Study Description
Brief Summary: To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer
Detailed Description: This is a Phase 3, open-label, randomized, multicenter study in approximately 360 adult female subjects with histologically- or cytologically-confirmed breast cancer that is metastatic for whom treatment with IV paclitaxel monotherapy has been recommended by their oncologist. Approximately 400 subjects will be enrolled to provide 360 evaluable subjects. The subjects must have measurable metastatic target lesion disease as per RECIST v1.1 criteria. Subjects will be randomized in a 2:1 ratio to either Oraxol or IV paclitaxel (as Taxol or generic).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centro de Investigacion Pergamino SA, Pergamino, Buenos Aires, Argentina
IONC, Ciudad de Córdoba, Cordoba, Argentina
Clinica Universitaria Privada Reina Fabiola, Córdoba, Cordoba, Argentina
Centro Oncologico Infinito, Santa Rosa, La Pampa, Argentina
Fundación Koriza, Santa Rosa, La Pampa, Argentina
Clinica Viedma, Viedma, Rio Negro, Argentina
COIBA, Buenos Aires, , Argentina
CEMEDIC, Ciudad Autónoma de Buenos Aires, , Argentina
Fundación Investigar, Ciudad Autónoma de Buenos Aires, , Argentina
Fundación Centro Oncológico Riojano Integral (CORI), La Rioja, , Argentina
Hospital Provincial del Centenario, Santa Fe, , Argentina
Instituto de Oncologia de Rosario, Santa Fe, , Argentina
Sanatorio Britanico, Santa Fe, , Argentina
Centro Medico San Roque, Tucuman, , Argentina
CAIPO, Tucumán, , Argentina
Fundación Arturo López Pérez, Santiago de Chile, , Chile
Hospital de Referencia de Salud Cordillera Unidad de Patología Mamaria, Santiago de Chile, , Chile
Hospital San Borja Arriarán, Santiago de Chile, , Chile
IRAM, Santiago de Chile, , Chile
Clínica Alemana Temuco, Temuco, , Chile
Instituto Nacional de Cancerología E.S.E., Bogota, , Colombia
Fundación Colombiana de Cancerología Clinica Vida, Medellín, , Colombia
Fundación Hospitalaria San Vicente de Paúl, Medellín, , Colombia
Hemato Oncologos S.A., Valle, , Colombia
Hospital Metropolitano de Santiago (HOMS), Santiago de los Caballeros, , Dominican Republic
Clinical Research, Santo Domingo, , Dominican Republic
Hospital General de la Plaza de la Salud, Santo Domingo, , Dominican Republic
Hospital SOLCA, Guayaquil, , Ecuador
Hospital Carlos Andrade Martín, Quito, , Ecuador
Hospital SOLCA, Quito, , Ecuador
Espemedic, San Salvador, , El Salvador
Hospital Diagnotico Clinica Oncologica & Cancer Research, San Salvador, , El Salvador
American Cancer Center, Guatemala City, , Guatemala
CELAN Clínica Médica, Guatemala City, , Guatemala
Clinica Privada, Guatemala city, , Guatemala
Clínica Privada, Guatemala City, , Guatemala
Grupo Angeles, S.A., Guatemala City, , Guatemala
Oncomedica en Guatemala, Guatemala City, , Guatemala
CRESEM, Quetzaltenango, , Guatemala
Excel Medica, Cortés, , Honduras
Tecnología en Investigación, Cortés, , Honduras
Centro Hemato Oncológico Panamá, Panama city, , Panama
Clínica Oncológica Miraflores, Lima, , Peru
Hospital Cayetano Heredia, Lima, , Peru
Hospital Nacional del Arzobispo Loayza, Lima, , Peru
Contact Details
Name: David Cutler, MD
Affiliation: Kinex Pharmaceuticals Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
