Last updated on June 2019

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


Brief description of study

The 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, or are ineligible for intensive induction therapy, and to determine the maximum tolerated dose or recommended phase 2 dose of Onvansertib in combination with decitabine or and Onvansertib in combination with low-dose cytarabine. In the phase 2 portion of the study, one regimen (either Onvansertib in combination with decitabine or Onvansertib in combination with low-dose cytarabine) 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.

Clinical Study Identifier: NCT03303339

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Allina Health Virginia Piper Cancer Institute

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