Spots Global Cancer Trial Database for Safety and Efficacy Study of PRI-724 in Subjects With Advanced Myeloid Malignancies
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Trial Identification
Brief Title: Safety and Efficacy Study of PRI-724 in Subjects With Advanced Myeloid Malignancies
Official Title: An Open-Label, Dose-Escalation Phase I/II Study of PRI-724 for Patients With Advanced Myeloid Malignancies
Study ID: NCT01606579
Study Description
Brief Summary: 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).
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Emory University / Winship Cancer Institute, Atlanta, Georgia, United States
University of Massachusetts Medical Center, Worcester, Massachusetts, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Duke University Medical Center, Durham, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Jorge Cortes, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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