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Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma

NCT02293005 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-10-04

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Alisertib

50 mg twice a day on Days 1-7 of each 21-day study cycle.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Anne S. Tsao, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-20
Primary Completion
2021-07-06
Completion
2021-07-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293005 on ClinicalTrials.gov