Calendario›AMGN›AMG 655
AMG 655
Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat
Ensayo de AMGEN INC en Hodgkin's Lymphoma · Low Grade Lymphoma · Lymphoma · Mantle Cell Lymphoma · Non-Hodgkin's Lymphoma · Diffuse Large Cell Lymphoma (del registro, en inglés).
Más ensayos de: Linfoma · Linfoma de células del manto · Linfoma no Hodgkin.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 33
- Fin del objetivo primario
- jul 2010
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2008.
Qué mide
Part 1: Safety: Subject incidence of treatment emergent adverse events, Dose Limiting Toxicities, the severity of adverse events and clinically significant changes in safety laboratory tests, physical examinations, or vital signs. (Length of Study) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a multi-center, phase 1b study of AMG 655 in combination with bortezomib or vorinostat in subjects with relapsed or refractory low grade lymphoma, mantle cell lymphoma, diffuse large cell lymphoma, and Hodgkin's disease. Part 1 is an open-label, dose-escalation phase (3+3 design) to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with bortezomib or vorinostat. Subjects will be enrolled into one of two arms based on investigator selection (either the bortezomib + AMG 655 arm or vorinostat + AMG 655 arm). Part 2 of the study is a dose expansion phase that will commence after dose selection of AMG 655 in combination with bortezomib in Part 1. In Part 2, subjects (n = 20) with mantle cell lymphoma will be given AMG 655 in combination with bortezomib. The dose of AMG 655 used in combination with bortezomib will be based on safety and pharmacokinetic information obtained from Part 1 as well as from ongoing AMG 655 trials.
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 (NCT00791011), actualizada en mar 2014.