NCT02293005

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Drug Administration: If you are found to be eligible to take part in this study, you will take alisertib tablets by mouth 2 times each day on Days 1-7 of each 21-day study cycle. You must take your doses of alisertib at least 6 hours apart with 1 cup (about 8 ounces) of water. If you miss or vomit a dose of alisertib, do not retake that dose. Wait and take the next dose as scheduled. Study Visits: On Day 1 of Cycles 1-3 and then every odd-numbered cycle after that (Cycles 5, 7, 9 and so on): * You will have a physical exam. * Blood (about 4 teaspoons) will be drawn for routine tests. Every 6 weeks while you are on study, you will have a PET-CT scan of your chest, abdomen, and pelvis to check the status of the disease. Length of Study: You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on this study will be over after you have completed follow-up. Follow up: Your study doctor or study team will follow you up 30 days after your last dose by reviewing your medical chart or calling you to see if the side effects are resolved. After that, you will continue to be followed up at 3 months, 6 months and every 6 months beyond that. The study doctor can explain how the study drug is designed to work. Up to 58 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

• Lung Cancer
• Mesothelioma

Interventions

Type	Name	Description
DRUG	Alisertib	50 mg twice a day on Days 1-7 of each 21-day study cycle.

Timeline

• Start date: 2015-05-20
• Primary completion: 2021-07-06
• Completion: 2021-07-06
• First posted: 2014-11-18
• Last updated: 2022-10-04
• Results posted: 2022-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study