Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055939
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2003-03-06
Brief Title:
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase II Study Of Intravenous DX-8951f EXATECAN MESYLATE Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma
Status:
COMPLETED
Status Verified Date:
2012-05
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractory rhabdomyosarcoma
PURPOSE Phase II trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractory rhabdomyosarcoma
Detailed Description:
OBJECTIVES
Determine the objective response rate complete and partial responses in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate
Determine the time to tumor progression in patients treated with this drug
Determine the median survival and survival at 6 and 12 months in patients treated with this drug
Assess pain in patients treated with this drug
Evaluate the quantitative and qualitative toxic effects of this drug in these patients
Evaluate the pharmacokinetics of this drug in these patients
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive exatecan mesylate IV over 30 minutes on days 1-5 Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 6 additional courses beyond CR
PROJECTED ACCRUAL A total of 13-27 patients will be accrued for this study within 1 year
Determine the objective response rate complete and partial responses in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate
Determine the time to tumor progression in patients treated with this drug
Determine the median survival and survival at 6 and 12 months in patients treated with this drug
Assess pain in patients treated with this drug
Evaluate the quantitative and qualitative toxic effects of this drug in these patients
Evaluate the pharmacokinetics of this drug in these patients
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive exatecan mesylate IV over 30 minutes on days 1-5 Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 6 additional courses beyond CR
PROJECTED ACCRUAL A total of 13-27 patients will be accrued for this study within 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 |
|---|---|---|---|
| SJCRH-DXRMS | None | None | None |
| DAIICHI-8951A-PRT033 | None | None | None |