Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 7:17 PM
Study NCT ID:
NCT01491633
Status:
TERMINATED
Last Update Posted:
2014-07-15
First Post:
2011-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dasatinib in Advanced Squamous Cell Lung Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Phase II Trial of Dasatinib in Advanced (Stage IIIB/IV) Squamous Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Safety issues/concerns per DF/HCC PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has been used in treatment for other types of cancer and information from other research studies suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially in individuals whose tumor has a mutation in the DDR2 gene.
Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic targets are needed. Several studies have examined dasatinib in NSCLC; these report significant toxicities, but also responses in patients found to harbor mutations in DDR2 or BRAF.
An open-label phase II trial with dasatinib was carried out to determine the response rates in patients with SqCC who had previously failed standard chemotherapy and to correlate responses with patient genotype.
Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic targets are needed. Several studies have examined dasatinib in NSCLC; these report significant toxicities, but also responses in patients found to harbor mutations in DDR2 or BRAF.
An open-label phase II trial with dasatinib was carried out to determine the response rates in patients with SqCC who had previously failed standard chemotherapy and to correlate responses with patient genotype.
Detailed Description:
Dasatinib will be taken orally, daily in cycles of 28 days.
On the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following:
* Medical history and clinical exam
* Safety blood tests
* Measurement of Performance Status
* Review of pill log
* CT scans will be done every 8 weeks.
In this research study, the investigators are looking at how well dasatinib works in treating squamous cell lung cancer.
Dasatinib administered at 140mg per day for the treatment of advanced SqCC of the lung is associated with excess adverse events, similar to other studies, so is not recommended in unselected patients. Further work to identify patients likely to benefit from dasatinib and in managing dasatinib-related toxicities is needed.
On the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following:
* Medical history and clinical exam
* Safety blood tests
* Measurement of Performance Status
* Review of pill log
* CT scans will be done every 8 weeks.
In this research study, the investigators are looking at how well dasatinib works in treating squamous cell lung cancer.
Dasatinib administered at 140mg per day for the treatment of advanced SqCC of the lung is associated with excess adverse events, similar to other studies, so is not recommended in unselected patients. Further work to identify patients likely to benefit from dasatinib and in managing dasatinib-related toxicities is needed.
Study Oversight
Has Oversight DMC:
True
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?: