A Phase 1b/2 Study of PCM-075 in Combination With Either Low-Dose Cytarabine or Decitabine in Subjects With Acute Myeloid Leukemia (AML)

What is the purpose of this trial?

The purpose of the phase 1b/2 study is to determine whether PCM-075 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 PCM-075 in combination with decitabine or and PCM-075 in combination with low-dose cytarabine. In the phase 2 portion of the study, one regimen (either PCM-075 in combination with decitabine or PCM-075 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.

Trovagene, Inc.

Start Date: 02/21/2018

End Date: 01/31/2020

Last Updated: 02/22/2018

Study HIC#: 2000021932