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Patient-Level Summary of Clinical Trial NCT02293005
A Clinical Trial Sponsored by M.D. Anderson Cancer Center
Clinical Trial Identifier NCT02293005
Sponsor
M.D. Anderson Cancer Center
Official Title
Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma
This Clinical Trial is for people with the following condition(s)
Lung Cancer
Mesothelioma
The Purpose of this Clinical Trial (provided by the Sponsor)
Objectives: Objectives The primary objective of this study is to: To assess 4-month disease control rate (DCR)
in pre-treated patients with unresectable malignant pleural mesothelioma (MPM) treated with alisertib The
secondary objectives of this study are to: To assess the response rate (confirmed and unconfirmed complete +
partial responses) To assess the progression-free survival. To assess overall survival. To evaluate the side effects
and toxicities associated with this treatment regimen. To collect archival tissue, blood, pleural effusion fluid and
plasma for correlative studies. Exploratory Objectives: To collect archival or new tissue, blood and pleural
effusion fluid for correlative studies. Tissue biomarkers to be evaluated include aurora kinase pathway and c-myc
gene amplification. Next generation sequencing (NGS) will be conducted on adequate tumor tissue specimens.
This Clinical Trial may involve the following Interventions, Drugs, or Procedures
Name
Type
Definition
Alisertib
Drug
A second-generation, orally bioavailable, highly
National Cancer
selective small molecule inhibitor of the
Institute Thesaurus
serine/threonine protein kinase Aurora A kinase
with potential antineoplastic activity. Alisertib
binds to and inhibits Aurora A kinase, which may
result in disruption of the assembly of the mitotic
spindle apparatus, disruption of chromosome
segregation, and inhibition of cell proliferation.
Aurora A kinase localizes to the spindle poles and
to spindle microtubules during mitosis, and is
thought to regulate spindle assembly. Aberrant
expression of Aurora kinases occurs in a wide
variety of cancers, including colon and breast
cancers.
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Patient-Level Summary of Clinical Trial NCT02293005
A Clinical Trial Sponsored by M.D. Anderson Cancer Center
Clinical Trial Design
Design
Definition
Definition Source
Efficacy Study
A study of the relative therapeutic efficacy of treatment of a
disease. Usually this is a Phase II or III study.
National Cancer
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Safety Study
A study of the relative safety of treatment of a disease. Usually
this is a Phase I or II trial.
National Cancer
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Single Group Study
A type of clinical study in which there is only one treatment arm
available to all study participants.
National Cancer
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Open Label Study
A type of study in which both the health providers and the
patients are aware of the drug or treatment being given.
National Cancer
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Terms
Treatment Study
A type of study protocol designed to evaluate intervention(s) for National Cancer
disease treatment.
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Additional Information about this Clinical Trial
See Glossary of Terms for
The number of people planned to enroll in this Clinical Trial is 58
Enrollment
United States Food and Drug Administration (FDA) regulated? Yes
FDA-Regulated Drug Study Indicator
This Clinical Trial is in Phase 2
Phase
This Clinical Trial is expected to be completed by
Study End Date
This Clinical Trial began in May 2015
Study Start Date
Glossary of Terms
Keyword
Definition
Definition Source
Enrollment
The act of registration, entering in a list, catalog, group, study;
also, the number of subjects enrolled.
National Cancer
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FDA-Regulated Drug Study
Indicator
An indication as to whether the study involves an FDA-regulated National Cancer
drug.
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Mesothelioma
A benign (noncancerous) or malignant (cancerous) tumor
affecting the lining of the chest or abdomen. Exposure to
asbestos particles in the air increases the risk of developing
malignant mesothelioma.
National Cancer
Institute Glossay of
Terms
Phase II Trial
A study to test whether a new treatment has an anticancer
effect (for example, whether it shrinks a tumor or improves
blood test results) and whether it works against a certain type
of cancer.
National Cancer
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Terms
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Patient-Level Summary of Clinical Trial NCT02293005
A Clinical Trial Sponsored by M.D. Anderson Cancer Center
Study End Date
The date on which the study concludes.
National Cancer
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Study Start Date
The date on which a study began.
National Cancer
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Information about this Record
ClinicalTrials.gov processed this data on January 12, 2017
Link to the current ClinicalTrials.gov record. https://clinicaltrials.gov/show/NCT02293005
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