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: Accepting New Patients
- 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, Multi-Center, Single Arm, Open-Label Study of Mocetinostat (MGCD0103) in Combination with Azacitidine in Subjects with Intermediate or High Risk Myelodysplastic Syndrome (MDS)
- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1/2 Open-Label, Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory 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, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects with Advanced Hematologic Malignancies with an IDH2 Mutation
- A Phase 1B Study to Evaluate the Safety and Preliminary Efficacy of Pf-04449913, an Oral Hedgehog Inhibitor, in Combination with Intensive Chemotherapy, Low Dose ARA-C or Decitabine in Patients with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
- A Phase IIa, Multicenter, Open-Label Study Designed to Evaluate the Safety and Efficacy of Escalating Doses of BL-8040 in Adult Subjects with Relapsed/Refractory Acute Myeloid Leukemia
- Open-Label Single Arm Phase 2 Study Evaluating Dasatinib Therapy Discontinuation In Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) With Stable Complete Molecular Response (CMR) DASFREE
- A Phase 1 Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse
- A Randomized Phase II Study of Oral Sapacitabine in Elderly Patients with Acute Myeloid Leukemia Previously Untreated or in First Relapse
- A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia
- Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age = 60 Years)
- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients with Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
- A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
last updated: 19-Dec-14 06:55 AM
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