Spots Global Cancer Trial Database for A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving
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Trial Identification
Brief Title: A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving
Official Title: A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving Translocation of the MLL Gene at 11q23 or Advanced Hematologic Malignancies
Study ID: NCT01684150
Interventions
Study Description
Brief Summary: The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing rearrangements of the MLL gene. Currently this study is in the MLL-r restricted/expansion phase and is only enrolling patients with rearrangements involving the MLL gene, including 11q23 or partial tandem duplications (PTD).
Detailed Description: A subset of patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) harbor rearrangements of the MLL gene, which are detected either by cytogenetic or fluorescent in situ hybridization evaluation at the time of diagnosis. A protein called DOT1L plays an important role in the malignant process in these leukemias. EPZ-5676 is a molecule that blocks the activity of DOT1L, and is therefore being evaluated in the treatment of patients with MLL-rearranged leukemias. The dose escalation portion has been completed. Currently this study is in the expansion phase and patients with MLL-r and MLL-PTD will receive EPZ-5676 as a 28-day continuous intravenous infusion (CIV).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Scottsdale-Phoenix, Scottsdale, Arizona, United States
Northwestern University, Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Health System, Durham, North Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
UT MD Anderson Cancer, Houston, Texas, United States
Universitätsklinikum Ulm, Ulm, , Germany
Erasmus University Medical Center, Rotterdam, , Netherlands
Contact Details
Name: Martin S. Tallman, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jesus Berdeja, MD
Affiliation: SCRI Development Innovations, LLC
Role: PRINCIPAL_INVESTIGATOR
Name: David A Rizzieri, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
Name: Guillermo Garcia-Manero, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Jessica Altman, MD
Affiliation: Northwestern University
Role: PRINCIPAL_INVESTIGATOR
Name: Raoul Tibes, MD
Affiliation: Mayo Clinic Scottsdale-Phoenix
Role: PRINCIPAL_INVESTIGATOR
Name: Mojca Jongen-Lavrencic, MD
Affiliation: Erasmus Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Hartmut Döhner, MD
Affiliation: Universitätsklinikum Ulm
Role: PRINCIPAL_INVESTIGATOR
Name: Ipsen Medical Director
Affiliation: Ipsen
Role: STUDY_DIRECTOR
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