A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome
Completed · Phase 2
Conditions studied: Acute Myelogenous Leukemia, High-Grade Myelodysplastic Syndrome
In brief
This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Key facts
- Study ID
- NCT00830518
- Run by
- Millennium Pharmaceuticals, Inc.
- People needed
- 57
- Starts
- 2009-02-10
- Expected to finish
- 2011-07-04
- Last updated by the study team
- 2018-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Each participants must meet all of the following inclusion criteria:
- Male or female participants 18 years or older
- Eligible diagnoses:
- Acute myelogenous leukemia (except acute promyelocytic leukemia [APL]) with > 10% bone marrow or peripheral blood blasts; failed to achieve complete response (CR) or relapse after prior therapy, not candidates for potentially curative treatment. Untreated participants > 60 are eligible if not candidates for standard induction.
- High-grade myelodysplastic syndrome (MDS), defined by all the following features: International Prognostic Scoring System (IPSS) Intermediate-2 or High Risk; > 10% blasts on bone marrow examination; treatment failure from, or not candidates for, standard therapies including demethylating agents, e.g. azacytidine or decitabine.
- Eastern Cooperative Oncology Group performance status 0-2
- Female participants:
- Postmenopausal for at least one year
- Surgically sterile, or
- If childbearing potential, agree to practice two effective methods of contraception or abstain from heterosexual intercourse.
- Male participants:
- Practice effective barrier contraception to one month after the last dose of study drug, or
- Abstain from heterosexual intercourse.
- Voluntary written consent
- Participants on hydroxyurea may be included
You may not qualify if…
- Pregnant or lactating females
- Known human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS) - related illness
- Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the protocol completion
- Total bilirubin > 1.5 × the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 × the ULN. AST, ALT may be elevated to 5 x the ULN if reasonably ascribed to underlying hematological disorder.
- Calculated creatinine clearance < 30 mL/minute
- Antineoplastic or radiotherapy within 14 days preceding the first dose
- Myocardial infarction within 6 months of enrollment or current history of New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
- Major surgery 14 days prior to the first dose
- Clinically uncontrolled central nervous system (CNS) involvement.
- Inability to swallow capsules
- History of uncontrolled sleep apnea or conditions that result in excessive daytime sleepiness, such as chronic lung disease
Where it is running
- Hematology and Oncology Associates of Northern New Jersey — Morristown, New Jersey, United States
Full record on ClinicalTrials.gov
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