A Phase 1b, Open-Label, Dose-Escalation Study of MLN4924 Plus Azacitidine in Treatment-Na´ve Patients With Acute Myelogenous Leukemia Who Are 60 Years or Older

This study is an open-label, multicenter, phase 1b, dose-escalation study of MLN4924 in combination with azacitidine in adult patients with AML. The patient population will consist of patients 60 years of age or older, previously diagnosed with World Health Organization(WHO)-defined AML, who are unlikely to benefit from standard induction therapy and who have not received definitive treatment for AML or prior treatment with azacitidine or decitabine. MLN4924 is a small molecule inhibitor of Nedd8 activating enzyme (NAE) with potential anticancer activity.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : MLN4924 and azacitidine

Phase: Phase 1

Eligibility

Ages Eligible For Study:

60 Years - N/A

Inclusion Criteria

- Patients with WHO-defined AML, 60 years of age or older, who are unlikely to benefit from standard induction therapy, defined as having at least 1 of the following: 1. Greater than or equal to 75 years of age 2. Antecedent hematologic disease 3. Known adverse cytogenetic risk 4. Eastern Eastern Cooperative Oncology Group (ECOG) PS = 2 - Patient must not have received definitive treatment for AML, defined as any prior chemotherapy with antileukemic activity - ECOG PS 0 to 2 - Expected survival longer than 3 months from enrollment in the study - Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence - Male patients who agree to practice effective barrier contraception or agree to practice true abstinence - Voluntary written consent must be given before performance of any study-related procedure - Suitable venous access for the study-required blood sampling - Adequate clinical laboratory values during the screening period as specified in the protocol - Able to undergo bone marrow aspiration and biopsy at screening

External Links

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Contact information

Primary Contact:

Marlene Zuraek (650) 736-4031

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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