Anemia in Patients With a Non-Myeloid Malignancy
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 08/31/2008 |
| Primero enviado: | 05/27/2002 |
| Inscripción estimada enviada: | 05/27/2002 |
| Publicado por primera vez: | 05/28/2002 |
| Última actualización enviada: | 09/10/2008 |
| Última actualización publicada: | 09/14/2008 |
| Fecha de inicio real del estudio: | 12/31/2001 |
| Fecha estimada de finalización primaria: | 09/30/2003 |
| Fecha estimada de finalización del estudio: | 03/31/2004 |
Condición o enfermedad
Intervención / tratamiento
Drug: Darbepoetin alfa
Drug: rHuEPO
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: rHuEPO | Drug: rHuEPO 150 IU/kg TIW |
| Experimental: Darbepoetin alfa | Drug: Darbepoetin alfa Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 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: - Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug - Screening hemoglobin concentration less than or equal to 11.0 g/dL - ECOG performance status of 0 to 2 (inclusive) Exclusion Criteria: - History of seizure disorder - Primary hematologic disorder that could cause anemia - Unstable or uncontrolled disease/condition related to or affecting cardiac function - Clinical evidence of chronic infection/inflammatory disease - Positive test for HIV infection - Previously confirmed neutralizing antibodies to rHuEPO - Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences |
Salir
Medidas de resultado primarias
1. Time to first hemoglobin response during the treatment period [during the treatment period]
Medidas de resultado secundarias
1. Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events [throughout study]
2. Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO) [throughout study]
3. Average weekly dosage of study drug during the 16-week treatment period [16-week treatment period]
4. Receiving red blood cell (RBC) transfusion from week 5 to week 12 [from week 5 to week 12]
5. Change in FACT-Fatigue scale score from baseline to week 7 [from baseline to week 7]
6. Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise [throughout study]
7. Profile of change in FACT-Fatigue scale score from baseline over the treatment period [from baseline over the treatment period]
8. Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP) [from baseline to EOTP]
9. Change in FACT-Physical Well-being scale score from baseline to EOTP [from baseline to EOTP]
10. Receiving RBC transfusion during the treatment period [during the treatment period]
11. Number of units of RBC transfused during the treatment period [during the treatment period]
12. Achieving a hemoglobin response by week 7 [baseline to week 7]
13. Change in hemoglobin concentration from baseline to EOTP [from baseline to EOTP]
14. Time to first hematopoietic response [throughout study]
15. Achieving a hemoglobin correction [throughout study]
16. Number and percentage of subjects who exceed the hemoglobin concentration threshold [throughout study]
