Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036959
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2002-05-13
Brief Title:
ABT-751 in Treating Young Patients With Refractory Solid Tumors
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Trial and Pharmacokinetic Study of ABT-751 an Orally Bioavailable Tubulin Binding Agent on a 7 Day and 21 Day Dosing Schedule in Pediatric Patients With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as ABT-751 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects of ABT-751 in treating young patients with refractory solid tumors
PURPOSE This phase I trial is studying the side effects of ABT-751 in treating young patients with refractory solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and dose-limiting toxic effects of ABT-751 administered daily for 7 days every 21 days or daily for 21 days every 28 days in children with refractory solid tumors
Determine the toxicity spectrum of these regimens in these patients
Determine the pharmacokinetics of these regimens in these patients
Evaluate the pharmacodynamics of this drug by measuring the fraction of tubulin that is polymerized in the peripheral blood mononuclear cells of these patients before and after receiving this drug
Secondary
Quantify responses in patients treated with these regimens
Assess the effect of this drug on tumor vascularity and tumor blood flow using dynamic enhanced MRI in these patients
OUTLINE This is an open-label multicenter dose-escalation study of 2 different schedules of ABT-751 Patients are assigned to 1 of 2 dosing schedules
Schedule 1 closed to accrual as of 5252009 Patients receive oral ABT-751 once daily on days 1-7 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Schedule 2 closed to accrual as of 5252009 Patients receive oral ABT-751 once daily on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
On each schedule cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined up to 9 patients a minimum of 3 patients age 11 and under and 3 patients age 12 to 18 are treated at the MTD
PROJECTED ACCRUAL A maximum of 90 patients will be accrued for this study within 8 months
Primary
Determine the maximum tolerated dose and dose-limiting toxic effects of ABT-751 administered daily for 7 days every 21 days or daily for 21 days every 28 days in children with refractory solid tumors
Determine the toxicity spectrum of these regimens in these patients
Determine the pharmacokinetics of these regimens in these patients
Evaluate the pharmacodynamics of this drug by measuring the fraction of tubulin that is polymerized in the peripheral blood mononuclear cells of these patients before and after receiving this drug
Secondary
Quantify responses in patients treated with these regimens
Assess the effect of this drug on tumor vascularity and tumor blood flow using dynamic enhanced MRI in these patients
OUTLINE This is an open-label multicenter dose-escalation study of 2 different schedules of ABT-751 Patients are assigned to 1 of 2 dosing schedules
Schedule 1 closed to accrual as of 5252009 Patients receive oral ABT-751 once daily on days 1-7 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Schedule 2 closed to accrual as of 5252009 Patients receive oral ABT-751 once daily on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
On each schedule cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined up to 9 patients a minimum of 3 patients age 11 and under and 3 patients age 12 to 18 are treated at the MTD
PROJECTED ACCRUAL A maximum of 90 patients will be accrued for this study within 8 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 |
|---|---|---|---|
| CDR0000069344 | None | None | None |
| 02-C-0141 | None | None | None |
| ABBOTT-M01-357 | None | None | None |