Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031616
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2002-03-08
Brief Title:
NB1011 in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Sponsor:
NewBiotics
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study Of NB1011 Administered Intravenously Daily For 5 Days Every 4 Weeks In Fluoropyrimidine-Resistant Metastatic Or Relapsed Colorectal Cancers
Status:
UNKNOWN
Status Verified Date:
2004-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 III trial to study the effectiveness of NB1011 in treating patients who have metastatic or recurrent colorectal cancer that has not responded to previous treatment
PURPOSE Phase III trial to study the effectiveness of NB1011 in treating patients who have metastatic or recurrent colorectal cancer that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of NB1011 in patients with fluoropyrimidine-resistant metastatic or recurrent colorectal cancer
Determine the safety and toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the efficacy of this drug in these patients
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Phase I Patients receive NB1011 IV over 1 hour on days 1-5 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of NB1011 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
Phase II Additional patients receive NB1011 at the MTD as in phase I Patients are followed at day 30 and then for 5 months
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for the phase I portion of this study A total of 15-25 patients will be accrued for the phase II portion of this study
Determine the maximum tolerated dose of NB1011 in patients with fluoropyrimidine-resistant metastatic or recurrent colorectal cancer
Determine the safety and toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the efficacy of this drug in these patients
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Phase I Patients receive NB1011 IV over 1 hour on days 1-5 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of NB1011 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
Phase II Additional patients receive NB1011 at the MTD as in phase I Patients are followed at day 30 and then for 5 months
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for the phase I portion of this study A total of 15-25 patients will be accrued for the phase II portion of this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V01-1689 | None | None | None |
| NB-1011-1001 | None | None | None |