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).
- 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 part of the study.
- To find the dose of PRI-724 that should be used in the second 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.
This will be a single center, open-label escalating-dose cohort study with 3 parts: Phase Ia
during which the MTD will be determined; Phase Ib expansion phase during which the
tolerability of the MTD will be further defined; and Phase II 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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
DLT (Dose Limiting Toxicity)
Observance of 1 DLT in first 3 patients during 3+3 phase will result in the enrollment of an additional 3 patients. Observance of 2+ DLTs in 6 patients during 3+3 phase will result in the next lower dose being expanded. Observance of DLTs in 33% of patients in 10 patient MTD expansion will result in the next lower dose being expanded. MTD will only be established in a dose level where 0/3 pts or 1/6 pts have a DLT observed in first 2 cycles of therapy. Two types of DLTs will be observed: non-hematologic and hematologic.
Jorge Cortes, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas M.D. Anderson Cancer Center||Houston, Texas 77030|