Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00114283
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2005-06-13
Brief Title:
Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Trial of GW572016 in Patients With Metastatic and Recurrent Squamous Cell Carcinomas of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2012-11
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 lapatinib ditosylate works in treating patients with metastatic or recurrent head and neck cancer Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I The primary objective of this study is to estimate the objective response rate complete response CR partial response PR in patients with squamous cell carcinomas of the head and neck following treatment with GW572016 lapatinib ditosylate
SECONDARY OBJECTIVES
I Secondary objectives of this study are to estimate time to progression describe the adverse event profile and to obtain preliminary assessments of changes in pre- versus post-treatment measurements for selected biomarkers in tumor cells from these patients
OUTLINE
Patients receive lapatinib ditosylate orally PO once daily QD Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year
I The primary objective of this study is to estimate the objective response rate complete response CR partial response PR in patients with squamous cell carcinomas of the head and neck following treatment with GW572016 lapatinib ditosylate
SECONDARY OBJECTIVES
I Secondary objectives of this study are to estimate time to progression describe the adverse event profile and to obtain preliminary assessments of changes in pre- versus post-treatment measurements for selected biomarkers in tumor cells from these patients
OUTLINE
Patients receive lapatinib ditosylate orally PO once daily QD Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year
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 |
|---|---|---|---|
| R21CA114986 | OTHER | US NIH GrantContract Award Number | None |
| NCI-2011-03823 | REGISTRY | None | None |
| HEAD AND NECK 04-3 | None | None | None |
| UVACC-33604 | None | None | None |
| CDR0000430924 | None | None | None |
| NCI-6697 | None | None | None |
| UVACC-HIC-11569 | OTHER | None | None |
| 6697 | OTHER | None | None |