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INCB053914
Study of INCB053914 in Subjects With Advanced Malignancies
Ensayo de INCYTE CORP en Tumor solido.
Más ensayos de: Tumor sólido.
- Fase
- Fase 1/2
- Estado
- Interrumpido
- Participantes
- 97
- Centros
- 19
- Fin del objetivo primario
- ago 2020
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2015.
Qué mide
Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events (del registro, en inglés) (unos 7 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).
Más ensayos de INCY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| tafasitamab · InMIND | Fase 3 | En marcha, sin reclutar | feb 2024 (real) |
| Tafasitamab · MINDway | Fase 1/2 | En marcha, sin reclutar | jul 2024 (real) |
| Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND) | no aplica | Reclutando pacientes | jun 2025 (prevista, ya pasada: sin actualizar en el registro) |
| tafasitamab · J-MIND | Fase 1/2 | En marcha, sin reclutar | jul 2025 (real) |
| INCA034176 | Fase 3 | En marcha, sin reclutar | ago 2025 (real) |
| Povorcitinib | Fase 3 | En marcha, sin reclutar | feb 2026 (real) |
Todos los de INCY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02587598), actualizada en nov 2021.