Alisertib for Acute Myeloid Leukemia

Completed · Phase 1

Conditions studied: Acute Myelogenous Leukemia

In brief

This research study is a Phase I clinical trial. Phase I trials test the safety of an investigational drug or combination of drugs. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it. As part of this research study, you will take alisertib in combination with idarubicin and cytarabine. Alisertib has not been approved by the FDA for your cancer. However, cytarabine and idarubicin have both been approved by the FDA for treatment of AML. It also means that the FDA has not approved giving alisertib with idarubicin and cytarabine for use in patients, including patients with your type of cancer. Idarubicin and cytarabine are chemotherapy agents that are commonly used to treat individuals diagnosed with AML. Alisertib has been used in laboratory studies and those studies suggest that alisertib may slow down the spread of your cancer. It does this by blocking certain substances needed by the cancer cells to spread. In this study, researchers would like to combine alisertib with standard chemotherapy (cytarabine and idarubicin) in order to see if it can be given safely with chemotherapy in individuals with AML. The primary purpose of this research study is to determine the highest dose that alisertib can be given with idarubicin and cytarabine without severe or unmanageable side effects. The dose identified in this study will be used in future research studies.

Key facts

Study ID: NCT01779843
Run by: Massachusetts General Hospital
People needed: 22
Starts: 2013-04-01
Expected to finish: 2016-11-01
Last updated by the study team: 2017-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Pathologically confirmed, newly diagnosed acute myelogenous leukemia
Agree to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of MLN8237
Able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after MLN8237 administration

You may not qualify if…

Have received systemic antineoplastic therapy, including radiotherapy within 14 days of study treatment, with the exception of hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction
Pregnant or breastfeeding
Presence of "favorable" or "better risk" cytogenic prognosis
Prior allogeneic bone marrow or organ transplantation
Diagnosis of acute bilineal/biphenotypic leukemia
History of a different malignancy except if disease-free for at least 5 years and at low risk or recurrence; or cervical cancer in situ, basal cell or squamous cell carcinoma of the skin within the past 5 years
Uncontrolled intercurrent illness
HIV positive on combination antiretroviral therapy
Diagnosis of active hepatitis B or C
Current or history of congestive heart failure NYHA class 3 or 4, or documented diastolic or systolic dysfunction
Current or history of ventricular or life threatening arrhythmias or diagnosis of long QT syndrome
Known history of uncontrolled sleep apnea syndrome or other condition that could result in excessive daytime sleepiness
Requirement for constant administration of proton pump inhibitor, H2 antagonist or pancreatic enzymes
Systemic infection requiring IV antibiotic therapy within 14 days of first dose of study drug
Treatment with clinically significant enzyme inducers

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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