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Last Updated: April 24, 2024

CLINICAL TRIALS PROFILE FOR ALISERTIB

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Clinical Trials for Alisertib

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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.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Summary

Clinical Trial Conditions for Alisertib

Condition Name

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Condition Name for
Intervention	Trials
Advanced Solid Tumors	8
Recurrent Mantle Cell Lymphoma	4
Diffuse Large B-cell Lymphoma	4
Small Cell Lung Cancer	3
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Condition MeSH

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

Trials by Country

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Trials by Country for
Location	Trials
United States	269
Canada	11
United Kingdom	8
Spain	6
Italy	5
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Trials by US State

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Trials by US State for
Location	Trials
Texas	24
Pennsylvania	15
New York	14
California	12
Tennessee	11
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Clinical Trial Progress for Alisertib

Clinical Trial Phase

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Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	18
Phase 1/Phase 2	5
[disabled in preview]	33
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Clinical Trial Status

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Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	40
Recruiting	5
Terminated	5
[disabled in preview]	8
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Clinical Trial Sponsors for Alisertib

Sponsor Name

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Sponsor Name for
Sponsor	Trials
Millennium Pharmaceuticals, Inc.	36
National Cancer Institute (NCI)	16
M.D. Anderson Cancer Center	4
[disabled in preview]	7
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Sponsor Type

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Sponsor Type for
Sponsor	Trials
Industry	41
Other	34
NIH	16
[disabled in preview]	0
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