Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095563
Status:
COMPLETED
Last Update Posted:
2017-04-18
First Post:
2004-11-05
Brief Title:
Lapatinib in Treating Patients With Recurrent andor Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of GW572016 in Recurrent andor Metastatic Adenoid Cystic Carcinoma and Other EGFR-andor erbB2-expressing Malignant Tumors of the Salivary Glands
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent andor metastatic adenoid cystic cancer or other salivary gland cancers Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the antitumor activity of GW572016 in recurrent andor metastatic adenoid cystic carcinoma of the salivary glands using objective response rates partial and complete responses
SECONDARY OBJECTIVES
I To determine the duration of objective response rate and duration of stable disease progression-free median and overall survival rates of GW572016 in recurrent andor metastatic adenoid cystic carcinoma of the salivary glands
II To estimate the antitumor activity of GW572016 in other epidermal growth factor receptor EGFR- andor erbB2-overexpressing malignant tumors of the salivary glands using objective response rates partial and complete responses
III To document the safety and tolerability of GW572016 in these patient populations
TERTIARY OBJECTIVES
I To investigate if differences in baseline levels of EGFR andor erbB2 expression and receptor phosphorylation status in tumor specimens predict outcome to therapy
II To investigate if the inhibitory effects of GW572016 on EGFR andor erbB2 pathway activation in tumor specimens correlate with clinical outcome
III To determine the steady state levels of GW572016 achieved and their correlation with clinical and laboratory correlative endpoints
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Patients are followed for survival
I To determine the antitumor activity of GW572016 in recurrent andor metastatic adenoid cystic carcinoma of the salivary glands using objective response rates partial and complete responses
SECONDARY OBJECTIVES
I To determine the duration of objective response rate and duration of stable disease progression-free median and overall survival rates of GW572016 in recurrent andor metastatic adenoid cystic carcinoma of the salivary glands
II To estimate the antitumor activity of GW572016 in other epidermal growth factor receptor EGFR- andor erbB2-overexpressing malignant tumors of the salivary glands using objective response rates partial and complete responses
III To document the safety and tolerability of GW572016 in these patient populations
TERTIARY OBJECTIVES
I To investigate if differences in baseline levels of EGFR andor erbB2 expression and receptor phosphorylation status in tumor specimens predict outcome to therapy
II To investigate if the inhibitory effects of GW572016 on EGFR andor erbB2 pathway activation in tumor specimens correlate with clinical outcome
III To determine the steady state levels of GW572016 achieved and their correlation with clinical and laboratory correlative endpoints
OUTLINE This is a nonrandomized open-label multicenter study
Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Patients are followed for survival
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 |
|---|---|---|---|
| N01CM62203 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62203 |
| NCI-2012-03089 | REGISTRY | None | None |
| 6701 | None | None | None |
| PHL-028 | OTHER | None | None |
| 6701 | OTHER | None | None |
| N01CM62201 | NIH | None | None |