Ignite Creation Date:
2024-05-05 @ 9:18 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00858403
Status:
TERMINATED
Last Update Posted:
2014-01-15
First Post:
2009-03-05
Brief Title:
Dasatinib in Advanced Non-small Cell Lung Cancer NSCL With Ex Vivo and In Vivo Assessment of Tumor Target Modulation
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study of Dasatinib in Advanced Non-small Cell Lung Cancer With Ex Vivo and In Vivo Assessment of Tumor Target Modulation
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to learn how patients with Advanced Non-Small Cell Lung Cancer NSCLC respond to the study drug Dasatinib The study drug Dasatinib has been approved by the US Food and Drug Administration FDA for treatment of leukemia but has not been approved for the treatment of other kinds of cancer The use of Dasatinib in this study is considered experimental
Detailed Description:
Cycle 1 Day 1 C1D1 Patients will have complete history and physical HP complete blood count CBC complete metabolic panel CMP and electrocardiogram EKG on day 1 Each cycle is 28 days The C1D1 EKG can be omitted if the patient has no new cardiac symptoms and has not starting taking any medication known to affect QT corrected for heart rate QTc prolongation Any residual toxicity from prior therapy for cancer will be recorded Blood will be drawn for assessment of serum markers The patient will begin dasatinib at the starting C1D1 on a daily basis
Cycle 1 Day 10-20 C1D10-20 Patients will have a second biopsy to obtain additional tumor material to examine biological effects of dasatinib on signaling pathways Dasatinib will be taken first thing in the morning and the patient will log the time Blood will also be drawn for pharmacokinetic assessments of dasatinib levels in plasma and the time recorded Four FNA aspirates and 2 core biopsies can be obtained either at the bedside for palpable lesions or through appropriate image-guided techniques CT or US at the discretion of the treating physician in consultation with radiology The time of the biopsy will be recorded One core biopsy should be immediately fixed in formalin and the other core biopsy should be snap frozen in liquid nitrogen
Cycle 2 Day 1 C2D1 Patients will be seen by the treating physician and have complete HP CBC and CMP Blood will be drawn for assessment of serum markers Toxicity of dasatinib will be assessed The patient will continue to take daily doses of dasatinib on a daily basis
Cycle 2 Day 22 C2D22 Patients will undergo reevaluation for tumor measurements This assessment can occur on C2D22 7 days
Cycle 1 Day 10-20 C1D10-20 Patients will have a second biopsy to obtain additional tumor material to examine biological effects of dasatinib on signaling pathways Dasatinib will be taken first thing in the morning and the patient will log the time Blood will also be drawn for pharmacokinetic assessments of dasatinib levels in plasma and the time recorded Four FNA aspirates and 2 core biopsies can be obtained either at the bedside for palpable lesions or through appropriate image-guided techniques CT or US at the discretion of the treating physician in consultation with radiology The time of the biopsy will be recorded One core biopsy should be immediately fixed in formalin and the other core biopsy should be snap frozen in liquid nitrogen
Cycle 2 Day 1 C2D1 Patients will be seen by the treating physician and have complete HP CBC and CMP Blood will be drawn for assessment of serum markers Toxicity of dasatinib will be assessed The patient will continue to take daily doses of dasatinib on a daily basis
Cycle 2 Day 22 C2D22 Patients will undergo reevaluation for tumor measurements This assessment can occur on C2D22 7 days
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 |
|---|---|---|---|
| CA180214 | OTHER | Bristol-Myers Squibb | None |