Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT00507767
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2007-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dasatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 2 Study of Dasatinib in Head and Neck Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-04
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 phase II trial studies how well dasatinib works in treating patients with head and neck cancer that has come back or spread to other areas of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the 12-week progression-free survival rate and the objective response rate, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with dasatinib.
SECONDARY OBJECTIVES:
I. To define metabolic response rate by positron emission tomography (PET) scan at 0, 8, and 12 weeks.
II. To define overall survival distribution from initiation of dasatinib. III. To define duration of response. IV. To determine if there is a correlation between clinical benefit from dasatinib (defined as disease response or stabilization) and pharmacokinetics, pharmacodynamics (phosphorylated Src \[pSrc\] expression in platelets), or changes in serum levels of cytokines, growth factors, and growth factor receptors relevant to the Src signaling pathway.
V. To examine the relationship between clinical benefit and mammary tumor and squamous cell carcinoma-associated protein (EMS1) gene amplification and cortactin expression levels in tumor tissue prior to therapy and the modulation of cortactin levels by treatment.
VI. To compare the effects of dasatinib on apoptosis by terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay in tumor tissues comparing pre- and post-treatment biopsies.
VII. To assess the tolerability of dasatinib in this patient population. VIII. To describe the pharmacokinetic (PK) profile and relative bioavailability of dasatinib suspension in patients receiving the drug through percutaneous gastrostomy tube.
IX. To descriptively assess safety, toxicity, and efficacy of dasatinib crushed and administered by feeding tube.
OUTLINE:
Patients receive dasatinib orally (PO) or via percutaneous gastrostomy (PEG) tube twice daily (BID). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 4 weeks.
I. To determine the 12-week progression-free survival rate and the objective response rate, as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with dasatinib.
SECONDARY OBJECTIVES:
I. To define metabolic response rate by positron emission tomography (PET) scan at 0, 8, and 12 weeks.
II. To define overall survival distribution from initiation of dasatinib. III. To define duration of response. IV. To determine if there is a correlation between clinical benefit from dasatinib (defined as disease response or stabilization) and pharmacokinetics, pharmacodynamics (phosphorylated Src \[pSrc\] expression in platelets), or changes in serum levels of cytokines, growth factors, and growth factor receptors relevant to the Src signaling pathway.
V. To examine the relationship between clinical benefit and mammary tumor and squamous cell carcinoma-associated protein (EMS1) gene amplification and cortactin expression levels in tumor tissue prior to therapy and the modulation of cortactin levels by treatment.
VI. To compare the effects of dasatinib on apoptosis by terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay in tumor tissues comparing pre- and post-treatment biopsies.
VII. To assess the tolerability of dasatinib in this patient population. VIII. To describe the pharmacokinetic (PK) profile and relative bioavailability of dasatinib suspension in patients receiving the drug through percutaneous gastrostomy tube.
IX. To descriptively assess safety, toxicity, and efficacy of dasatinib crushed and administered by feeding tube.
OUTLINE:
Patients receive dasatinib orally (PO) or via percutaneous gastrostomy (PEG) tube twice daily (BID). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 4 weeks.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00227 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000559148 | None | None | View | |
| 2006-0571 | OTHER | M D Anderson Cancer Center | View | |
| 7815 | OTHER | CTEP | View | |
| N01CM62202 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |