Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459342
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2007-04-09
Brief Title:
Dasatinib in Treating Patients With Stage IIIB Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Dasatinib in Non Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth This phase II trial is studying how well dasatinib works in treating patients with stage IIIB stage IV or recurrent non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib
SECONDARY OBJECTIVES
I Determine the rate of response in patients treated with this drug II Examine the relationship between clinical response to this drug and epidermal growth factor receptor EGFR mutational status EGFR copy number and phosphorylated Src pSrc expression levels in pre-treatment tumor biopsies
III Determine the toxicity of this drug
OUTLINE
Patients received oral dasatinib twice daily on days 1-21 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization FISH for epidermal growth factor receptor and by immunohistochemistry for pSrc expression
I Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib
SECONDARY OBJECTIVES
I Determine the rate of response in patients treated with this drug II Examine the relationship between clinical response to this drug and epidermal growth factor receptor EGFR mutational status EGFR copy number and phosphorylated Src pSrc expression levels in pre-treatment tumor biopsies
III Determine the toxicity of this drug
OUTLINE
Patients received oral dasatinib twice daily on days 1-21 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization FISH for epidermal growth factor receptor and by immunohistochemistry for pSrc expression
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000538668 | None | None | None |
| NCI-2009-00225 | REGISTRY | None | None |
| 2006-0593 | None | None | None |
| 7798 | OTHER | None | None |
| 2006-0593 | OTHER | None | None |
| N01CM62202 | NIH | None | None |
| P30CA016672 | NIH | CTEP | httpsreporternihgovquickSearchP30CA016672 |