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MLL-r and MLL-PTD 28-day continuous IV infusion of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity develops.

EPZ-5676

Martin S. Tallman, MD

Jesus Berdeja, MD

David A Rizzieri, MD

Guillermo Garcia-Manero, MD

Jessica Altman, MD

Raoul Tibes, MD

Mojca Jongen-Lavrencic, MD

Hartmut Döhner, MD

Ipsen Medical Director

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).

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).

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

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

The MTD is defined as the dose level below in which \>1 patient out of 3 or \>2 patients out of 6 experience dose-limiting adverse events (as defined by the protocol).

analysis of Cmax, AUC and steady state concentration

Evaluation of adverse events, vital signs, physical examination, 12-lead ECG, and laboratory assessments

Evaluation of response by standard criteria for AML or ALL

Celgene

Epizyme, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT01684150	Acute Myeloid L... Acute Lymphobla... Myelodysplastic... Myeloproliferat...	EPZ-5676	18 Years - 90 Years	Ipsen
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	NCT01684150	Acute Myeloid L... Acute Lymphobla... Myelodysplastic... Myeloproliferat...	EPZ-5676	18 Years - 90 Years	Ipsen

Spots Global Cancer Trial Database for mixed lineage leukemia (mll)