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An Open-Label, Dose Escalation, Phase 1 Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Acute Myelogenous Leukemia,Myelodysplastic Syndrome, and Acute Lymphoblastic Leukemia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

Thank you

Trial Information

An Open-Label, Dose Escalation, Phase 1 Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Acute Myelogenous Leukemia,Myelodysplastic Syndrome, and Acute Lymphoblastic Leukemia


Inclusion Criteria:



- Age greater than or equal to 18 years

- Have the following diagnosis:

- AML or ALL (for the dose escalation phase only)including leukemia secondary to
prior chemotherapy or resulting from an antecedent hematologic disorder, who
have failed to achieve complete response (CR) or who have relapsed after prior
therapy and are not candidates for potentially curative treatment.

- Acute Promyelocytic Leukemia (APL) patients are not eligible

- AML or ALL patients who are over age 60 and have not received prior therapy are
also eligible if they are not candidates for standard induction chemotherapy

- High-grade MDS, defined as > 10% blasts on bone marrow examination

- Low-grade MDS, defined as < 10% blasts on bone marrow examination (Schedule B
expansion cohort only)

- Patients who are willing to refrain from donating blood for at least 90 days after
their final dose of MLN4924 and (for male patients) willing to refrain from donating
semen for at least 4 months after their final dose of MLN4924

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Female patients who are postmenopausal, surgically sterile, or agree to practice 2
effective methods of contraception or abstain from heterosexual intercourse

- Male patients who agree to practice 2 effective methods of contraception or abstain
from heterosexual intercourse

- Voluntary written consent

- Suitable venous access

- Adequate clinical laboratory values during the screening period as specified in the
protocol

- Patients who are on hydroxyurea may be included in the study and may continue on
hydroxyurea while participating in this study.

Exclusion Criteria:

- Female patients who are lactating or have a positive serum pregnancy test during the
screening period

- Any serious medical or psychiatric illness

- Treatment with any investigational products

- Systemic antineoplastic therapy or radiotherapy within 14 days before the first dose
of study drug, except for hydroxyurea

- Major surgery within 14 days before the first dose of study drug

- Life-threatening illness unrelated to cancer

- Clinically uncontrolled central nervous system (CNS) involvement

- Known human immunodeficiency virus (HIV) positive

- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
infection

- Evidence of uncontrolled cardiovascular conditions as specified in the protocol

- Diarrhea > Grade 1, based on the NCI CTCAE categorization

- Systemic treatment with prohibited medications

- Ongoing anticoagulant therapy (eg, aspirin, Coumadin, heparin) that cannot be held to
permit bone marrow sampling

- Use of acetaminophen, acetaminophen-containing products, and statins are not
permitted on the day before dosing, day of dosing, and day after dosing with MLN4924

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events, serious adverse events, assessments of clinical laboratory values, and vital sign measurements

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C15003

NCT ID:

NCT00911066

Start Date:

July 2009

Completion Date:

September 2013

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Stanford University Medical CenterStanford, California  94305-5408
Institute for Drug DevelopmentSan Antonio, Texas  78245-3217
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Johns Hopkins Kimmel Cancer CenterBaltimore, Maryland  21231-1000
Robert H. Lurie Comprehensive Cancer Center Northwestern UniversityChicago, Illinois  60657