Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00095667
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2004-11-05
Brief Title:
Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of GW572016 in Hormone Naive Recurrent or Metastatic Hormone Sensitive Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the antitumor activity of GW572016 in hormone naïve recurrent andor metastatic hormone sensitive prostate cancer using PSA response rate
SECONDARY OBJECTIVES
I To estimate objective tumor response in patients with measurable disease II To determine the duration of PSA response rate and duration of stable disease progression-free median and overall survival rates of GW572016 in recurrent andor metastatic prostate cancer
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 correlates with clinical outcome
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
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 117 months
I To determine the antitumor activity of GW572016 in hormone naïve recurrent andor metastatic hormone sensitive prostate cancer using PSA response rate
SECONDARY OBJECTIVES
I To estimate objective tumor response in patients with measurable disease II To determine the duration of PSA response rate and duration of stable disease progression-free median and overall survival rates of GW572016 in recurrent andor metastatic prostate cancer
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 correlates with clinical outcome
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
PROJECTED ACCRUAL A total of 21-41 patients will be accrued for this study within 117 months
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 |
|---|---|---|---|
| PHL-030 | None | None | None |
| CDR394173 | None | None | None |
| N01CM62203 | NIH | None | httpsreporternihgovquickSearchN01CM62203 |