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Last Updated: July 16, 2024

CLINICAL TRIALS PROFILE FOR ALISERTIB


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Clinical Trials for Alisertib

Trial ID Title Status Sponsor Phase Summary
NCT00500903 ↗ A Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Participants With Advanced Solid Tumors Completed Millennium Pharmaceuticals, Inc. Phase 1 To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237 when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by a 14-day recovery period.
NCT00651664 ↗ A Phase I Clinical and Pharmacodynamic Study of MLN8237, A Novel Aurora A Kinase Inhibitor, in Participants With Advanced Malignancies Completed Millennium Pharmaceuticals, Inc. Phase 1 This is a multicenter, dose escalation, phase 1 study of MLN8237 in adult participants with advanced malignancies (excluding those with primary bone marrow involvement, such as leukemias and multiple myeloma).
NCT00697346 ↗ Study of MLN8237 in Participants With Advanced Hematological Malignancies Completed Millennium Pharmaceuticals, Inc. Phase 1 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.
NCT00807495 ↗ Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma Completed Millennium Pharmaceuticals, Inc. Phase 2 The purpose of this study is to evaluate the anti-tumor activity of alisertib (MLN8237) in participants with relapsed or refractory non-hodgkin's lymphoma.
NCT00830518 ↗ A Phase 2 Trial of MLN8237 in Adult Participants With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome Completed Millennium Pharmaceuticals, Inc. Phase 2 This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
NCT00853307 ↗ MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma Completed Millennium Pharmaceuticals, Inc. Phase 2 The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in the treatment of participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.
NCT00962091 ↗ Study of MLN8237 in Participants With Advanced Solid Tumors Completed Millennium Pharmaceuticals, Inc. Phase 1 The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characterize the effect of food on the single-dose pharmacokinetics (PK) of alisertib OS and enteric-coated tablets (ECT), to characterize the multiple-dose safety, tolerability, and steady-state PK of alisertib administered as an OS, and to characterize the multiple-dose safety and tolerability of alisertib administered as an ECT.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Alisertib

Condition Name

Condition Name
Intervention Trials
Advanced Solid Tumors 8
Diffuse Large B-Cell Lymphoma 4
Small Cell Lung Cancer 4
Recurrent Mantle Cell Lymphoma 4
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Condition MeSH

Condition MeSH
Intervention Trials
Lymphoma 17
Neoplasms 11
Lymphoma, B-Cell 8
Adenocarcinoma 8
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Clinical Trial Locations for Alisertib

Trials by Country

Trials by Country
Location Trials
United States 283
Canada 11
United Kingdom 8
Spain 6
Italy 5
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Trials by US State

Trials by US State
Location Trials
Texas 25
Pennsylvania 16
New York 14
California 12
Tennessee 12
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Clinical Trial Progress for Alisertib

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase Trials
Phase 3 2
Phase 2 19
Phase 1/Phase 2 5
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Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase Trials
Completed 40
Recruiting 6
Active, not recruiting 5
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Clinical Trial Sponsors for Alisertib

Sponsor Name

Sponsor Name
Sponsor Trials
Millennium Pharmaceuticals, Inc. 36
National Cancer Institute (NCI) 16
M.D. Anderson Cancer Center 4
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Sponsor Type

Sponsor Type
Sponsor Trials
Industry 42
Other 34
NIH 16
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