Clinical Trial DRUG EPZ-5676-12-001
- A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies
- Principal Investigator
- Jessica Altman
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG EPZ-5676-12-001
- The purpose of this study is to find out the effects, good and bad, that EPZ-5676 has on patients and their cancer.
- This study is for patients who have been diagnosed with leukemia or other cancer of the blood that is not responsive to currently approved treatments or for which no currently approved therapy is available. This research study involves the medication EPZ-5676. EPZ-5676 is an investigational drug. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). Animal studies have shown that EPZ-5676 is able to stop the formation of certain types of leukemia cells by turning off genes that are believed to cause the leukemia to form, when given as a continuous intravenous (IV) infusion for 21 days of a 28-day cycle. While the study drug has been thoroughly tested for safety in animals, this is the first study in which it will be given to humans
Some of the eligibility criteria include:
- Participants must have a diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), acute mixed lineage leukemia (MLL), myelodysplastic syndrome, myeloproliferative disorder, or chronic myeloid leukemia (CML).
- Participants must have had at least one prior therapy and no other standard treatments are available.
- Participants must have cancer that has relapsed (returned) after their most recent therapy.
- Participants must be 18 or older.
- Description of Treatment
- Study participants will be given a continuous dose of the study drug through a central IV line for 21 days of each 28-day cycle. Participants may continue to be treated as long as their disease is not getting worse and their are not unacceptable side effects.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Jessica Altman
- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation
- A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Hematologic Malignancies with an IDH1 and/or IDH2 Mutation
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
last updated: 25-May-16 03:46 PM
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