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Novel Erythropoiesis…
Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy
Ensayo de AMGEN INC en Anemia · Tumor solido.
Más ensayos de: Anemia · Tumor sólido.
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 405
- Fin del objetivo primario
- mar 2002
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jul 1999.
Qué mide
Occurence of adverse events and antibody formation to NESP (throughout the study) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to assess the safety of NESP administered by SC injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy. Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a sequential dose escalation study which consists of Parts A and B. Part A is the initial treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A. Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the initial treatment phase, where the CED of NESP administered every 4 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.
Más ensayos de AMGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Inebilizumab | Fase 3 | En marcha, sin reclutar | abr 2024 (real) |
| inebilizumab · MINT | Fase 3 | En marcha, sin reclutar | may 2024 (real) |
| Tarlatamab · DeLLphi-304 | Fase 3 | En marcha, sin reclutar | ene 2025 (real) |
| Tarlatamab · DeLLphi-307 | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Maridebart Cafraglutide | Fase 2 | En marcha, sin reclutar | oct 2025 (real) |
| Erenumab Dose 1 · OASIS(EM) | Fase 3 | En marcha, sin reclutar | nov 2025 (real) |
Todos los de AMGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00540384), actualizada en may 2013.