Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02293005
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2014-11-11
Brief Title:
Phase II Trial of Alisertib MLN8237 in Salvage Malignant Mesothelioma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Trial of Alisertib MLN8237 in Salvage Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-02568 | REGISTRY | NCI CTRP | None |