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PAS-004 Tablets
PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas
Ensayo de Pasithea Therapeutics Corp. en NF1 Mutation · Neurofibroma Plexiform · Neurofibroma, Plexiform · Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs) · Neurofibromatosis Type 1 (NF1) (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Reclutando pacientes
- Participantes
- 56
- Centros
- 5
- Fin del objetivo primario
- sep 2027
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en may 2025.
Qué mide
Part A: To evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle (Part A from enrollment (Day 1) through Day 28 (completion of Cycle 1)) (del registro, en inglés)
Qué se prueba
Se prueba PAS-004, tomado por via oral, en personas con al menos un neurofibroma plexiforme sintomatico debido a Neurofibromatosis Tipo 1, para ver como toleran distintas dosis y que efectos secundarios produce.
Lo que dice el documentoThe main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1). The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PAS-004 might have.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1). The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PAS-004 might have. This study will have two parts, Part A and Part B. The main goal of Part A of this study is to learn more about how participants tolerate different doses of PAS-004, and what side effects PAS-004 might have. What we learn from Part A of the study will help decide what doses of the study drug (PAS-004) should be used in Part B of the study, and if it is safe. In Part B, two different doses from Part A will be tested. The main goal of this part of the study is to keep studying any side effects of PAS-004 at those two dose levels, and to learn more about if the doses picked for this part of the study might have an effect on plexiform neurofibromas. Participants in Part A of the study who were taking doses selected for Part B may be able to continue on to Part B and keep taking the same dose of PAS-004 for 6 more months. Study participants in both parts will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety, including blood draws and MRIs. Everyone participating in the study will take PAS-004 by mouth once a day during the study, in 28-day cycles. Participants will be asked to keep a diary to record their daily dose of study drug. Participants will continue on daily PAS-004 for up to 6 months, or until: * They decide to withdraw from the study, or * They experience unacceptable side effects, or * Their disease progresses, or another illness interferes with taking the study drug, or * The sponsor selects a dose level to study further in the next part of the study, or * The sponsor stops the study.
Más ensayos de KTTA
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| PAS-004 Capsules | Fase 1 | Reclutando pacientes | feb 2026 (prevista, ya pasada: sin actualizar en el registro) |
Todos los de KTTA, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06961565), actualizada en nov 2025.