Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444015
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2007-03-05
Brief Title:
Phase I DasatinibErlotinib in Recurrent Non-small Cell Lung Cancer NSCLC
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase I Trial Evaluating the Epidermal Growth Factor Receptor Inhibitor Erlotinib in Combination With the SRC Kinase Inhibitor Dasatinib for Patients With Recurrent Non-small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2011-06
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 is a single site phase I dose escalation trial of the epidermal growth factor receptor inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with previously treated advanced stage Stage IIIBIV disease Non-Small Cell Lung Cancer NSCLC The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle If there are no Dose Limiting Toxicities DLTs dose escalation continues The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability
Detailed Description:
This is a single site Phase I dose escalation trial of the epidermal growth factor receptor inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with previously treated advanced stage Stage IIIBIV disease Non-Small Cell Lung Cancer NSCLC The screening evaluation will consist of a medical history including datesdescription of your initial NSCLC diagnosis and documentation of any previous treatment There will also be a physical examination including vital signs height weight Eastern Cooperative Oncology Group ECOGperformance status blood draws for Complete Blood Count CBC and Complete Metabolic Panel CMP tests neurological examination a pregnancy test for female patients of childbearing potential and if applicable any observable tumor measurements all within 14 days before study enrollment A screening Electrocardiogram EKG as well as clinical testing to evaluate all known sites of malignant lesions including Computed Tomography CTs of the chest and upper abdomen the adrenal glands ultrasound or radionuclide scans of the bones andor other radiographic studies should be performed within 30 days prior to enrollment
The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle If there are no DLTs dose escalation continues Patients continuing on therapy past two cycles will be seen by the treating physician every 4 weeks and will have complete History and Physical HP CBC and CMP Tumor measurement and response assessment will occur every 6-8 weeks Dasatinib and Erlotinib will be continued until progression of disease unacceptable toxicity or patient request
The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability
The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle If there are no DLTs dose escalation continues Patients continuing on therapy past two cycles will be seen by the treating physician every 4 weeks and will have complete History and Physical HP CBC and CMP Tumor measurement and response assessment will occur every 6-8 weeks Dasatinib and Erlotinib will be continued until progression of disease unacceptable toxicity or patient request
The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability
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 |
|---|---|---|---|
| BMS Protocol Number CA180080 | OTHER | Bristol-Myers Squibb | None |