Ignite Creation Date:
2024-05-06 @ 7:22 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02521051
Status:
UNKNOWN
Last Update Posted:
2019-11-26
First Post:
2015-07-20
Brief Title:
Phase III Trial of Alectinib and Bevacizumab in Patients With Advanced Anaplastic Lymphoma Kinase ALK-Positive Non-Small Cell Lung Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase III Trial to Evaluate the Safety and Tolerability of Alectinib and Bevacizumab in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
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:
This research study is evaluating two drugs alectinib and bevacizumab as possible treatments for Advanced Non-Small Cell Lung Cancer NSCLC
Detailed Description:
This is a Phase III clinical trial
A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate doses of the investigational intervention to use for further studies
Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease
Investigational means that the intervention is being studied
In this research study the investigators are investigating the combination of two study drugs alectinib and bevacizumab The FDA the US Food and Drug Administration has not approved alectinib as a treatment for any disease
It has been found that some people with NSCLC have a change mutation in a certain gene called the anaplastic lymphoma receptor tyrosine kinase ALK gene This mutated gene helps cancer cells grow
-- Alectinib belongs to a class of drugs designed to inhibit ALK This drug has been used in other research studies Information from those other research studies suggests that alectinib may be effective in killing cancer cells that have changes in ALK Only participants with changes in the ALK gene will be allowed to participate in this study
In this research study Alectinib will be combined with Bevacizumab
-- Bevacizumab also called Avastin works by slowing or stopping the growth of cells in cancer tumors by decreasing the blood supply of the tumors If blood supply is decreased oxygen and nutrients that are needed for tumor growth are decreased The FDA has approved Bevacizumab as a treatment option for your disease
The purpose of this study is to test the safety of Alectinib and Bevacizumab The investigators will also determine how effective this combination is in participants with advanced ALK-positive NSCLC with a focus on participants with brain metastases
A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate doses of the investigational intervention to use for further studies
Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease
Investigational means that the intervention is being studied
In this research study the investigators are investigating the combination of two study drugs alectinib and bevacizumab The FDA the US Food and Drug Administration has not approved alectinib as a treatment for any disease
It has been found that some people with NSCLC have a change mutation in a certain gene called the anaplastic lymphoma receptor tyrosine kinase ALK gene This mutated gene helps cancer cells grow
-- Alectinib belongs to a class of drugs designed to inhibit ALK This drug has been used in other research studies Information from those other research studies suggests that alectinib may be effective in killing cancer cells that have changes in ALK Only participants with changes in the ALK gene will be allowed to participate in this study
In this research study Alectinib will be combined with Bevacizumab
-- Bevacizumab also called Avastin works by slowing or stopping the growth of cells in cancer tumors by decreasing the blood supply of the tumors If blood supply is decreased oxygen and nutrients that are needed for tumor growth are decreased The FDA has approved Bevacizumab as a treatment option for your disease
The purpose of this study is to test the safety of Alectinib and Bevacizumab The investigators will also determine how effective this combination is in participants with advanced ALK-positive NSCLC with a focus on participants with brain metastases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None