drugset / Trial / NCT01486784

A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia

NCT01486784

Phase 1/2 Terminated 27 enrolled Abramson Cancer Center at Penn Medicine
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This was initially a phase I/II, open-label non-randomized study using an investigational new drug, TL32711, in patients with AML, MDS and ALL, however, the phase II portion was never initiated. This study initially targeted subjects 60 years of age and older (with non-M3 AML who have relapsed or refractory disease after standard therapy or who are newly diagnosed and subjects 18-59 (relapsed or refractory after failing 3 prior lines of therapy), and then targeted subjects 18 years of age and older with MDS and ALL.

Timeline

Start
2011-11
Primary completion
2014-11
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Birinapant Small molecule 17 mg/m2 Intravenous
Subject Birinapant Small molecule 22 mg/m2 Intravenous
Subject Birinapant Small molecule 26 mg/m2 Intravenous