Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084422
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2004-06-10
Brief Title:
N2001-03 CEP-701 in Treating Young Patients With Recurrent or Refractory High-Risk Neuroblastoma
Sponsor:
New Approaches to Neuroblastoma Therapy Consortium
Organization:
New Approaches to Neuroblastoma Therapy Consortium
Study Overview
Official Title:
A Phase I Study Of CEP-701 In Patients With Refractory Neuroblastoma IND 67722
Status:
COMPLETED
Status Verified Date:
2023-04
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 CEP-701 may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PURPOSE This phase I trial is studying the side effects and best dose of CEP-701 in treating young patients with recurrent or refractory high-risk neuroblastoma
PURPOSE This phase I trial is studying the side effects and best dose of CEP-701 in treating young patients with recurrent or refractory high-risk neuroblastoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of CEP-701 in pediatric patients with recurrent or refractory high-risk neuroblastoma
Determine the dose-limiting toxicity of this drug in these patients
Determine the pharmacokinetic behavior of this drug in these patients
Secondary
Determine the degree of TrkB tyrosine kinase inhibition activity present in the serum of patients treated with this drug
Correlate the degree of TrkB tyrosine kinase inhibition activity in these patients with dose level pharmacokinetics and antitumor activity data of this drug
Determine the antitumor activity of this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral CEP-701 twice daily on days 1-5 8-12 15-19 and 22-26 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
NOTE On day 1 of course 1 only patients receive oral CEP-701 once instead of twice
Cohorts of 3-6 patients receive escalating doses of CEP-701 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 Once the MTD is determined the dose level is expanded up to 9 patients
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of CEP-701 in pediatric patients with recurrent or refractory high-risk neuroblastoma
Determine the dose-limiting toxicity of this drug in these patients
Determine the pharmacokinetic behavior of this drug in these patients
Secondary
Determine the degree of TrkB tyrosine kinase inhibition activity present in the serum of patients treated with this drug
Correlate the degree of TrkB tyrosine kinase inhibition activity in these patients with dose level pharmacokinetics and antitumor activity data of this drug
Determine the antitumor activity of this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral CEP-701 twice daily on days 1-5 8-12 15-19 and 22-26 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
NOTE On day 1 of course 1 only patients receive oral CEP-701 once instead of twice
Cohorts of 3-6 patients receive escalating doses of CEP-701 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 Once the MTD is determined the dose level is expanded up to 9 patients
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
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 |
|---|---|---|---|
| NANT-2001-03 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA081403 |
| P01CA081403 | NIH | None | None |