Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03131206
Status:
TERMINATED
Last Update Posted:
2021-09-27
First Post:
2017-04-19
Brief Title:
A Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 12 Study of Alectinib in RET-rearranged Non-small Cell Lung Cancer or RET-mutated Thyroid Cancer
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed due to slow accrual and lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research trial is studying a drug called alectinib as a possible treatment for non-small cell lung cancer NSCLC with specific genetic alterations known as ALK or RET rearrangements and thyroid cancer with RET rearrangements
Detailed Description:
This is a Phase III research study which means that researchers are testing different doses of the drug alectinib in participants with cancer to evaluate its safety determine a safe dosage range and identify side effects
The FDA the US Food and Drug Administration has approved alectinib as a treatment option for NSCLC but at a different dosage
There are two parts to this study Phase 1 and Phase 2 In Phase 1 patients with ALK or RET rearranged NSCLC will receive different doses of alectinib to determine the highest dose that can be administered without severe or unmanageable side effects This is called the maximum tolerated dose and will be the recommended dose for the next part of the study Phase 2 A Phase I clinical trial tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies Investigational means that the drug is being studied
During Phase 2 participants with RET rearranged NSCLC or thyroid cancer will be given the maximum tolerated dose During both Phase 1 and Phase 2 the investigators will determine the effect alectinib has on the body and the effect alectinib has on cancer
Alectinib belongs to a class of drugs known as tyrosine kinase inhibitors which stop tyrosine kinases from working Tyrosine kinases are enzymes that are responsible for activating many proteins in the bodys cells The ALK and RET kinases play an important role in the survival and growth of tumor cells and in the ability of tumor cells to spread to different parts of the body In laboratory studies and in patients alectinib has been shown to block the ALK and RET kinases By blocking these kinases and stopping them from working it is hoped that alectinib may prevent the survival of tumor cells in addition to stopping their growth and ability to spread
The purpose of this research study is to learn about the effects of the study drug alectinib and to find the best dose for treating ALK-positive or RET-positive cancers
The FDA the US Food and Drug Administration has approved alectinib as a treatment option for NSCLC but at a different dosage
There are two parts to this study Phase 1 and Phase 2 In Phase 1 patients with ALK or RET rearranged NSCLC will receive different doses of alectinib to determine the highest dose that can be administered without severe or unmanageable side effects This is called the maximum tolerated dose and will be the recommended dose for the next part of the study Phase 2 A Phase I clinical trial tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies Investigational means that the drug is being studied
During Phase 2 participants with RET rearranged NSCLC or thyroid cancer will be given the maximum tolerated dose During both Phase 1 and Phase 2 the investigators will determine the effect alectinib has on the body and the effect alectinib has on cancer
Alectinib belongs to a class of drugs known as tyrosine kinase inhibitors which stop tyrosine kinases from working Tyrosine kinases are enzymes that are responsible for activating many proteins in the bodys cells The ALK and RET kinases play an important role in the survival and growth of tumor cells and in the ability of tumor cells to spread to different parts of the body In laboratory studies and in patients alectinib has been shown to block the ALK and RET kinases By blocking these kinases and stopping them from working it is hoped that alectinib may prevent the survival of tumor cells in addition to stopping their growth and ability to spread
The purpose of this research study is to learn about the effects of the study drug alectinib and to find the best dose for treating ALK-positive or RET-positive cancers
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