Status:
COMPLETED
A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Acute Myelogenous Leukemia
High-Grade Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Detailed Description
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat people who have acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS). This st...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2011
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00830518
Start Date
February 10 2009
End Date
July 4 2011
Last Update
May 11 2018
Active Locations (1)
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1
Hematology and Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States, 07962