Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099060
Status:
COMPLETED
Last Update Posted:
2014-01-27
First Post:
2004-12-08
Brief Title:
Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of GW572016 in Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2012-04
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:
RATIONALE Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE This phase III trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme
PURPOSE This phase III trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme
Detailed Description:
OBJECTIVES
Phase I
Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-inducing anti-epileptic drugs EIAEDs
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Phase II
Determine the efficacy of this drug in terms of objective tumor response rate in patients who are taking EIAEDs and in those who are not taking EIAEDs
Correlate immunohistochemical measures of cellular proteins and receptors from tumor samples with anti-tumor activity of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter open-label phase I dose-escalation study followed by a phase II study
Phase I Patients receive oral lapatinib twice daily on days 1-28 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of lapatinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive lapatinib as in phase I at the MTD Patients are followed at 1 month and then periodically for survival Patients with stable or responding disease who go off therapy are followed every 3 months for up to one year and then periodically thereafter for survival
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for the phase I portion of this study within 18 months A total of 15-30 patients will be accrued for the phase II portion of this study within 18 months
Phase I
Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-inducing anti-epileptic drugs EIAEDs
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Phase II
Determine the efficacy of this drug in terms of objective tumor response rate in patients who are taking EIAEDs and in those who are not taking EIAEDs
Correlate immunohistochemical measures of cellular proteins and receptors from tumor samples with anti-tumor activity of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter open-label phase I dose-escalation study followed by a phase II study
Phase I Patients receive oral lapatinib twice daily on days 1-28 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of lapatinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive lapatinib as in phase I at the MTD Patients are followed at 1 month and then periodically for survival Patients with stable or responding disease who go off therapy are followed every 3 months for up to one year and then periodically thereafter for survival
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for the phase I portion of this study within 18 months A total of 15-30 patients will be accrued for the phase II portion of this study within 18 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 |
|---|---|---|---|
| CDR0000389155 | OTHER | PDQ | None |
| CAN-NCIC-IND170 | None | None | None |