Ignite Creation Date:
2024-05-06 @ 10:16 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03202940
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2017-06-12
Brief Title:
A Phase IBII Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged ALK NSCLC
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase IBII Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged ALK NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
This research study is studying a drug combination as a possible treatment for anaplastic lymphoma kinase-positive ALK non-small cell lung cancer
The drugs involved in this study are
Alectinib
Cobimetinib
The drugs involved in this study are
Alectinib
Cobimetinib
Detailed Description:
This is a Phase III clinical trial A Phase I clinical trial tests the safety of investigational drugs or new combinations of approved drugs In addition a Phase I study tries to define the appropriate dose of the investigational drugs to use for further studies Investigational means that the drugs are being studied Following the phase I study additional participants will be enrolled to the Phase II component The phase II component will test the safest doses of alectinib and cobimetinib as identified in the Phase I component in a larger group of patients
The FDA the US Food and Drug Administration has approved alectinib as a treatment option for this disease
The FDA has not approved cobimetinib as a treatment for this specific disease However cobimetinib is approved for treatment of melanoma another type of cancer
Alectinib is an oral ALK inhibitor made by the pharmaceutical company Genentech The term ALK inhibitor means that alectinib targets the abnormal ALK protein that is causing your lung cancer cells to grow Alectinib has been tested in other clinical research studies and results show that the drug may help stop the growth and spread of ALK lung cancer cells
Cobimetinib is an oral inhibitor of MEK a signaling protein that can cause some types of lung cancer to grow Cobimetinib is also made by Genentech Laboratory studies suggest that ALK and MEK may work together to help ALK lung cancer cells grow In the laboratory combination treatment with drugs targeting ALK and MEK prevented lung cancer cells from growing It is possible that combination treatment with alectinib and cobimetinib will work better than alectinib alone to control the spread of the cancer
In this research study the investigators are trying to determine whether the combination of alectinib and cobimetinib is safe and well tolerated This study will help determine the doses of the drugs that should be used in the Phase II portion of this study Another purpose of this study is to determine whether adding cobimetinib to alectinib is effective for treating lung cancer that has already stopped responding to alectinib alone In order to help understand why the cancer may have stopped responding to alectinib and whether treatment with the two drugs effectively blocks growth signals all participants in this study will have periodic blood collections and undergo multiple biopsies
The FDA the US Food and Drug Administration has approved alectinib as a treatment option for this disease
The FDA has not approved cobimetinib as a treatment for this specific disease However cobimetinib is approved for treatment of melanoma another type of cancer
Alectinib is an oral ALK inhibitor made by the pharmaceutical company Genentech The term ALK inhibitor means that alectinib targets the abnormal ALK protein that is causing your lung cancer cells to grow Alectinib has been tested in other clinical research studies and results show that the drug may help stop the growth and spread of ALK lung cancer cells
Cobimetinib is an oral inhibitor of MEK a signaling protein that can cause some types of lung cancer to grow Cobimetinib is also made by Genentech Laboratory studies suggest that ALK and MEK may work together to help ALK lung cancer cells grow In the laboratory combination treatment with drugs targeting ALK and MEK prevented lung cancer cells from growing It is possible that combination treatment with alectinib and cobimetinib will work better than alectinib alone to control the spread of the cancer
In this research study the investigators are trying to determine whether the combination of alectinib and cobimetinib is safe and well tolerated This study will help determine the doses of the drugs that should be used in the Phase II portion of this study Another purpose of this study is to determine whether adding cobimetinib to alectinib is effective for treating lung cancer that has already stopped responding to alectinib alone In order to help understand why the cancer may have stopped responding to alectinib and whether treatment with the two drugs effectively blocks growth signals all participants in this study will have periodic blood collections and undergo multiple biopsies
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