C-906289-002: R289, an IRAK1/4 Inhibitor, in Lower-Risk MDS R/R Resistant to Prior Therapies - Clinical Trial

¿Cuál es el Propósito de este estudio?

In this study, people will take a medicine called R289 by mouth once or twice a day. The study has two parts: one part is to find the best dose, and the other part is to test two different doses.

You may take the medicine at home or at the clinic. You will visit the clinic regularly for tests like blood work, physical check-ups, and heart exams. Some visits may take up to 8 hours.

You can stay in the study as long as the medicine is helping and the side effects are not too strong.

¿Cuál es la Condición que se está estudiando?

Lower-risk myelodysplastic syndromes (LR-MOS).

¿Quién puede participar en el Estudio?

People in this study must:

- Be 18 years old or older.

- Have a blood problem called lower-risk myelodysplastic syndromes (LR-MDS).

- Have tried other treatments that did not work or the disease came back.

- May need regular red blood cell transfusions to feel better.

- Cannot be pregnant or breastfeeding.

Grupo etario
Adultos

¿Qué Implica?

This study is testing a new medicine called R289 to see if it can help people with a blood problem called lower-risk myelodysplastic syndromes (LR-MDS). Doctors want to learn how safe the medicine is and how well it works. They also want to find the best dose and see if it can help people need fewer blood transfusions.

Detalles del Estudio

Título Completo
An Open-Label, Phase 1b Study of R289, an IRAK1/4 Inhibitor, in Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) who are Relapsed/Refractory/Resistant to Prior Therapies
Investigador Principal
Harry P. Erba, MD, PhD
Especialista en oncología hematológica
Número de Protocolo
IRB: PRO00118897
NCT: NCT05308264
Fase
Fase I
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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