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


Phase 1
60 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia

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Trial Information

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


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

Exclusion Criteria:

- Previous treatment with azacitidine or decitabine

- Known favorable cytogenetic risk

- Any serious medical or psychiatric illness

- Treatment with any investigational products

- Known hypersensitivity to azacitidine or mannitol

- Acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow,
by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone
marrow, or by other accepted analysis

- Active uncontrolled infection or severe infectious disease

- 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

- Known hepatic cirrhosis or severe pre-existing hepatic impairment

- Known cardiac/cardiopulmonary disease

- Left ventricular ejection fraction

- Known moderate to severe chronic obstructive pulmonary disease, interstitial lung
disease, and pulmonary fibrosis

- Body mass index > 40 kg/m²

- Treatment with CYP3A inducers within 14 days before the first dose of MLN4924

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

- Patients who are unwilling or unable to refrain from using hydroxymethylglutaryl
coenzyme A (HMG CoA) reductase inhibitors (statins) starting 5 days before the
initial study drug administration and throughout the study will not be permitted to
enroll

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Adverse events

Outcome Description:

To assess the safety and tolerability of MLN4924 in combination with azacitidine.

Outcome Time Frame:

Recorded from the first dose of any study drug through 30 days (+ 10 days) after the last dose of study drug

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:

C15009

NCT ID:

NCT01814826

Start Date:

April 2013

Completion Date:

February 2016

Related Keywords:

  • Acute Myelogenous Leukemia
  • MLN4924
  • Acute
  • Myelogenous
  • Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

University of Miami School of MedicineMiami, Florida  33136
Sarah Cannon Research InstituteNashville, Tennessee  37203
Rocky Mountain Blood and Marrow Transplant ProgramDenver, Colorado  80218