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Onvansertib

Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

Ensayo de Cardiff Oncology, Inc. en Leucemia mieloide aguda.

Más ensayos de: Leucemia mieloide aguda.

Fase

Fase 1/2

Estado

Completado

Participantes

72

previstos

Centros

9

Fin del objetivo primario

nov 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2017.

Qué mide

Number of Participants Who Experienced Dose Limiting Toxicities (DLT) (Up to Day 28 of Cycle 1) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of the phase 1b/2 study is to determine whether Onvansertib given orally daily for 5 consecutive days every 28 days is safe and tolerable in adult patients who have relapsed/refractory Acute Myeloid Leukemia (AML), or are ineligible for intensive induction therapy, and to determine the maximum tolerated dose and recommended phase 2 dose of Onvansertib in combination with decitabine or Onvansertib in combination with low-dose cytarabine. In the phase 2 portion of the study, Onvansertib in combination with decitabine will be studied to provide further data on the safety profile of the combination and to preliminarily assess the activity of the chosen combination in patients with untreated AML who are not candidates for aggressive induction therapy, or who have received one prior treatment for their AML.

Más ensayos de CRDF

Todos los de CRDF, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03303339), actualizada en ene 2023.