Clinical trial · Interventional
A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome
A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome
NCT00830518CI-TRIAL-00032875completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| High-Grade Myelodysplastic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alisertib | Drug | Alisertib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alisertib
- description
- Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period, in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).
- interventionNames
- Drug: Alisertib
Primary outcomes (1)
- measure
- Best Overall Response Rate (ORR) Based on Investigator's Assessment
- timeFrame
- Baseline and every 2 cycles up to Cycle 16 (up to Month 12), from Cycle 17 every 4 cycles until disease progression, after end of treatment every 12 weeks for up to 12 Months (Approximately 2.4 years)
- description
- Best ORR is defined as the number of participants with complete remission(CR) or partial remission(PR) assessed by the Investigator using modified AML/MDS International Working Group(IWG) Criteria. AML:CR=neutrophils \>1x10\^9/L, platelets \>100x10\^9/L, bone marrow blasts(BMB) \<5%, transfusion independent, no extramedullary disease(EMD); CRi=BMB \<5%, transfusion independent, no EMD; PR=neutrophils \>1x10\^9/L, platelets \>100x10\^9/L, BMB \>50% decrease and 5% to 25%, blasts \<5% with Auer rods; PRi=BMB \>50% decrease and 5% to 25%. MDS:CR=bone marrow: ≤5% myeloblasts with normal maturation, peripheral blood: hemoglobin ≥11 g/dL, platelets ≥100x10\^9/L, neutrophils ≥1.0x10\^9/L, blasts 0%; PR=all CR criteria if abnormal before treatment except: BMB decreased by ≥50% over pretreatment but still \>5%; PRi=BMB decreased by ≥50% over pretreatment but still \>5%; Marrow CR=bone marrow: ≤5% myeloblasts and decrease by ≥50% over pretreatment, peripheral blood hematologic improvement responses noted.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Each participants must meet all of the following inclusion criteria: 1. Male or female participants 18 years or older 2. 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. 3. Eastern Cooperative Oncology Group performance status 0-2 4. 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. 5. Male participants: * Practice effective barrier contraception to one month after the last dose of study drug, or * Abstain from heterosexual intercourse. 6. Voluntary written consent 7. Participants on hydroxyurea may be included Exclusion Criteria: 1. Pregnant or lactating females 2. Known human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS) - related illness 3. Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the protocol completion 4. Total bilirubin \> 1.5 × the upper limit of normal (ULN) 5. 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. 6. Calculated creatinine clearance \< 30 mL/minute 7. Antineoplastic or radiotherapy within 14 days preceding the first dose 8. 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 9. Major surgery 14 days prior to the first dose 10. Clinically uncontrolled central nervous system (CNS) involvement. 11. Inability to swallow capsules 12. History of uncontrolled sleep apnea or conditions that result in excessive daytime sleepiness, such as chronic lung disease
References
Publications (0)
Data not yet available
No reference posted for this study.