Chemotherapy Related Anemia
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 04/30/2013 |
| Primero enviado: | 05/02/2002 |
| Inscripción estimada enviada: | 05/02/2002 |
| Publicado por primera vez: | 05/05/2002 |
| Última actualización enviada: | 05/08/2013 |
| Última actualización publicada: | 05/12/2013 |
| Fecha de inicio real del estudio: | 11/30/2001 |
| Fecha estimada de finalización primaria: | 11/30/2002 |
| Fecha estimada de finalización del estudio: | 03/31/2003 |
Condición o enfermedad
Intervención / tratamiento
Drug: Darbepoetin alfa SC
Drug: Darbepoetin alfa IV
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Darbepoetin alfa SC | Drug: Darbepoetin alfa SC Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W |
| Experimental: Darbepoetin alfa IV | Drug: Darbepoetin alfa IV Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Diagnosed with a non-myeloid malignancy - Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug - Screening hemoglobin concentration less than or equal to 11.0g/dL - ECOG performance status of 0 to 2 - Adequate renal and liver function Exclusion Criteria: - History of seizure disorder - Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1 - More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1 |
Salir
Medidas de resultado primarias
1. Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP) [from baseline to the end of treatment period (EOTP)]
Medidas de resultado secundarias
1. Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration [throughout study]
2. Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP [from baseline to week 7 and from week 7 to EOTP]
3. Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period [during the treatment period]
4. Time to and percentage of subjects with a hemoglobin response during the treatment period [during the treatment period]
5. Percentage of subjects who exceed the hemoglobin threshold [throughout study]
6. Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events [throughout study]
7. Incidence, if any, of neutralizing antibody formation to darbepoetin alfa [throughout study]
