Acute Myelogenous Leukemia Clinical Trial
Official title:
A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome
This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
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 study looked at the antitumor activity in people who received alisertib.
The study enrolled 57 patients. Participants were categorized by disease sub-types AML and
MDS. Participants received:
• Alisertib 50 mg
All participants took alisertib capsules every 12 hours each day for 7 days followed by a
14-day rest period in 21-day cycles for approximately 26 cycles.
This multi-center trial was conducted in North America and France. The overall time to
participate in this study was until there is evidence of disease progression or unacceptable
treatment-related toxicity. The participant could continue treatment beyond 12 months if it
was considered by the Sponsor and the Investigator that they would derive benefit from
continued alisertib treatment. Participants had weekly blood work and clinic visits, with
disease assessments every 2 cycles (ie. every 6 weeks) up to and including Cycle 16. Reduced
visits (every 12 weeks) were conducted for participants tolerating treatment beyond Cycle 16
and for participants off treatment without disease progression.
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