Clinical trial · Interventional
Study of MLN8237 in Participants With Advanced Hematological Malignancies
An Open-label, Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Hematological Malignancies
NCT00697346CI-TRIAL-00038865completedPhase 1Results 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 1 study of MLN8237 in participants with advanced hematological malignancies for whom there are limited standard treatment options.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| B-Cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| B-cell Follicular Lymphoma | — | UNRESOLVED | — |
| B-cell Mantle Cell Lymphoma | — | UNRESOLVED | — |
| B-cell Marginal Zone Lymphoma | — | UNRESOLVED | — |
| B-cell Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ALIAS | 0.90 |
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Enteropathy Associated T-cell Lymphoma | Enteropathy-Associated T-Cell Lymphoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alisertib | Drug | Alisertib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1: PIC Dose Escalation
- description
- Alisertib 25 or 35 mg, Powder-in-Capsule (PIC) formulation, orally, once daily (QD) for 21 days followed by a 7-day recovery period in 28-day cycles or alisertib 35, 45, 65 or 90 mg PIC, orally, (QD for 14 days followed by a 14-day recovery period in 28-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 14 cycles). All participants received an initial starting dosage of alisertib PIC 25 mg, orally, twice daily (BID) on Day 1 (loading dose), followed by their respective dosage assignment.
- interventionNames
- Drug: Alisertib
- type
- EXPERIMENTAL
- label
- Part 1: ECT Dose Escalation
- description
- Alisertib 40 mg, Enteric-coated Tablet (ECT) formulation, orally, QD for 14 days followed by a 14-day recovery period in 28-day cycles, or alisertib 30, 40 or 50 mg ECT, orally BID for 7 days followed by a 14-day recovery period in 21-day cycles, until disease progression or unacceptable alisertib-related toxicity (up to 15 cycles).
- interventionNames
- Drug: Alisertib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory disease and a histologically or cytologically confirmed hematological malignancy of the following type for which standard curative treatment does not exist or is no longer effective: * B-cell Follicular lymphoma * B-cell Marginal zone lymphoma * Diffuse large B-cell lymphoma * B-cell Mantle cell lymphoma * B-cell Small lymphocytic lymphoma (SLL) * B-Cell Chronic lymphocytic leukemia (B-CLL) * Multiple myeloma * Waldenstrom's macroglobulinemia * Noncutaneous peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) * Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma, enteropathy associated T-cell lymphoma (EATCL), NK lymphoma (NKL) * Participants with diffuse large B-cell lymphoma must have failed, be ineligible for, or have refused an autologous stem cell transplant. There is no restriction regarding the maximum number of prior regimens. * Aged 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Radiographically or clinically evaluable disease for Part 1 of this study and measurable disease for Part 2 of this study * Suitable venous access for the conduct of blood sampling for MLN8237 pharmacokinetics (PK) * Recovered from the reversible effects of prior antineoplastic treatment (with the exception of alopecia and Grade 1 neuropathy) Exclusion Criteria: * Pregnant or lactating * Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 as specified in the protocol * Prior allogeneic bone marrow (or other organ) transplantation * Newly diagnosed or uncontrolled cancer-related central nervous system (CNS) disease * Systemic antineoplastic treatment within 21 days preceding the first dose of study treatment. Exceptions requiring a 42-day recovery period from last treatment include: Nitrosoureas, mitomycin C or Rituximab, alemtuzumab (Campath®), or other unconjugated therapeutic antibody (21 days if clear evidence of progressive disease) * Treatment with radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan (Zevalin™), or tositumomab (Bexxar®) within 56 days preceding the first dose of study treatment * Antineoplastic treatment with glucocorticoids within 21 days preceding the first dose of study treatment * Radiotherapy involving \<25% of the hematopoietically active bone marrow within 21 days preceding first dose of study treatment * Radiotherapy involving ≥25% of the hematopoietically active bone marrow within 42 days preceding first dose of study treatment * Inability to swallow capsules or known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of MLN8237. Examples include, but are not limited to, partial gastrectomy, history of small intestine surgery, and celiac disease. * History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease * Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. Testing is not required in the absence of clinical findings or suspicion. * Participants who fail to meet laboratory values as specified in the protocol during the screening period
References
Publications (1)
- DERIVEDKelly KR, Shea TC, Goy A, Berdeja JG, Reeder CB, McDonagh KT, Zhou X, Danaee H, Liu H, Ecsedy JA, Niu H, Benaim E, Iyer SP. Phase I study of MLN8237--investigational Aurora A kinase inhibitor--in relapsed/refractory multiple myeloma, non-Hodgkin lymphoma and chronic lymphocytic leukemia. Invest New Drugs. 2014 Jun;32(3):489-99. doi: 10.1007/s10637-013-0050-9. Epub 2013 Dec 20. PMID 24352795