Phase II Trial of Alisertib (MLN8237) in Salvage Malignant Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02293005|
Recruitment Status : Completed
First Posted : November 18, 2014
Results First Posted : October 4, 2022
Last Update Posted : October 4, 2022
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|
|Actual Primary Completion Date :||July 6, 2021|
|Actual Study Completion Date :||July 6, 2021|
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 at 4 Months [ Time Frame: 4 months from treatment started ]Patients who are free of disease progression at 4 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Response Rate [ Time Frame: From treatment start, every 6 weeks until progression, death, withdrawal of consent or study completion an average of 25 months ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Overall Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 35 months ]Overall Survival is defined as the time from the date of randomization to the date of death due to any cause.
- Progression Free Survival (PFS) [ Time Frame: From treatment start to death/progression or last follow-up, whichever come first assessed up to 25 months. ]PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or RECIST 1.1 if mRECIST cannot be used.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|