Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma
|ClinicalTrials.gov Identifier: NCT02293005|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2014
Last Update Posted : May 10, 2019
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Mesothelioma||Drug: Alisertib||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma|
|Actual Study Start Date :||May 20, 2015|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2022|
Alisertib administered by mouth at 50 mg twice a day for 7 days in each treatment cycle, followed by a 14-day, treatment-free period.
50 mg twice a day on Days 1-7 of each 21-day study cycle.
Other Name: MLN8237
- Disease Control Rate (DCR) [ Time Frame: 4 months ]Trial conducted by Simon's minimax two-stage design and disease control rate at 4 months estimated accordingly (Simon, 1989). New regimen will have a target disease control rate of 50% at 4 months. A disease control rate of 30% or lower is considered a failure and the new regimen will be rejected under this circumstance.
- Response Rate [ Time Frame: 6 weeks ]Participants re-staged every 2 cycles of therapy. 1 cycle = 21 days or 3 weeks. Imaging studies consist of any of the following studies: PET-CT scans, chest CT scans, abdominal-pelvic CT scans. Modified RECIST (preferred) or RECIST (if modified RECIST cannot be used) measurements performed after every 2 cycles of therapy. The radiologist or the PI will review and determine response based on the RECIST.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293005
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Anne S. Tsao, MD||M.D. Anderson Cancer Center|