Acute Myeloid Leukemia Clinical Trial
Official title:
An Open-Label, Dose-Escalation Phase I/II Study of PRI-724 for Patients With Advanced Myeloid Malignancies
PRI-724 is a new investigational drug being studied to treat subjects with cancer who have advanced myeloid malignancies. PRI-724 is thought to work by blocking the Wnt signaling pathway that cancer cells need to grow and spread (metastasize).
PRI-724 is a new investigational drug being studied to treat subjects with cancer who have
advanced myeloid malignancies. PRI-724 is thought to work by blocking the Wnt signaling
pathway that cancer cells need to grow and spread (metastasize).
Purpose:
- To test the safety of PRI-724 when taken intravenously (through the vein).
- To observe whether PRI-724 can slow or stop the progression of leukemia.
- To find the Maximum Tolerated Dose (highest safe dose) in the first two parts of the
study.
- To find the dose of PRI-724 that should be used in the third part of the study and
possible future clinical trials that will study effectiveness and additional safety.
- To test the safety of combining PRI-724 with an approved cancer drug called dasatinib in
treating chronic myeloid leukemia (CML).
- To evaluate whether the combination of PRI-724 with the approved cancer drug dasatinib
slows or stops the progression of chronic myeloid leukemia (CML).
- To test the safety of combining PRI-724 with an approved cancer drug called Cytarabine
in treating acute myelogenous leukemia (AML).
- To evaluate whether the combination of PRI-724 with the approved cancer drug Cytarabine
slows or stops the progression of acute myelogenous leukemia (AML).
- To measure how much PRI-724 appears and remains in the blood after infusion.
- To measure several signals called biomarkers associated with cancer in the blood to see
if PRI-724 affects those signals.
Study Design:
This will be a single center, open-label escalating-dose cohort study with 3 parts: Part I
during which the MTD will be determined in acute group patients; Part II during which the MTD
will be determined in non-acute group patients; and Part III during which safety and
tolerability of escalating doses of PRI-724 will be assessed in combination with dasatinib
for CML patients or low dose ara-C therapy for AML patients ≥ 65 years of age.
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