Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-01-02 @ 7:21 PM
Study NCT ID:
NCT00493857
Status:
TERMINATED
Last Update Posted:
2008-11-17
First Post:
2007-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Nimotuzumab and Irinotecan in Metastatic Colorectal Cancer
Sponsor:
YM BioSciences
Organization:
Study Overview
Official Title:
A Phase II Open-Label, 2-Cohort Study of Nimotuzumab 400 mg Weekly Plus Irinotecan (Cohort 1) and Nimotuzumab 400 mg Every 2 Weeks Plus Irinotecan (Cohort 2) in Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Cohort 2 not going forward. Manadate changes in Company
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine if nimotuzumab provides a benefit in this type of cancer when given in combination with irinotecan.
The study will test:
* How long any good effects last.
* How bad any side effects are.
Objectives:
Primary:
The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer
Secondary:
* To assess the incidence of Grade 2 or greater acneiform rash or infusion reaction, allergic reaction or anaphylactoid reaction AEs in patients with irinotecan-refractory metastatic colorectal cancer following weekly or 2-weekly nimotuzumab schedules;
* To assess Progression-Free Survival (PFS), defined as time from date of randomization until date of disease progression (clinical or radiological) or death due to any cause, for the two nimotuzumab schedules;
* To assess the rates and durations of Stable Disease (SD) following weekly or 2-weekly nimotuzumab schedules;
* To assess the Time to Disease Progression (TTP) following weekly or 2-weekly nimotuzumab schedules;
* To evaluate ORR in patients who are identified as having "primary" irinotecan resistance following weekly or 2-weekly nimotuzumab schedules;
* To evaluate Overall Survival (OS) following weekly or 2-weekly nimotuzumab schedules;
* To compare the two dosing schedules of nimotuzumab with respect to objective response rates and safety;
* To evaluate the overall safety and toxicity profiles of these two dose regimens of nimotuzumab;
* To evaluate trough levels and accumulation of nimotuzumab in serum of patients receiving the drug on weekly or 2-weekly regimens.
The study will test:
* How long any good effects last.
* How bad any side effects are.
Objectives:
Primary:
The primary goal is to assess the Objective Response Rate (ORR) that the combination of irinotecan and nimotuzumab will produce in patients with irinotecan-refractory metastatic colorectal cancer
Secondary:
* To assess the incidence of Grade 2 or greater acneiform rash or infusion reaction, allergic reaction or anaphylactoid reaction AEs in patients with irinotecan-refractory metastatic colorectal cancer following weekly or 2-weekly nimotuzumab schedules;
* To assess Progression-Free Survival (PFS), defined as time from date of randomization until date of disease progression (clinical or radiological) or death due to any cause, for the two nimotuzumab schedules;
* To assess the rates and durations of Stable Disease (SD) following weekly or 2-weekly nimotuzumab schedules;
* To assess the Time to Disease Progression (TTP) following weekly or 2-weekly nimotuzumab schedules;
* To evaluate ORR in patients who are identified as having "primary" irinotecan resistance following weekly or 2-weekly nimotuzumab schedules;
* To evaluate Overall Survival (OS) following weekly or 2-weekly nimotuzumab schedules;
* To compare the two dosing schedules of nimotuzumab with respect to objective response rates and safety;
* To evaluate the overall safety and toxicity profiles of these two dose regimens of nimotuzumab;
* To evaluate trough levels and accumulation of nimotuzumab in serum of patients receiving the drug on weekly or 2-weekly regimens.
Detailed Description:
The patient will receive nimotuzumab every 2 weeks plus irinotecan. Nimotuzumab will be given at a dose of 400 mg once every 2 weeks for 12 weeks. Irinotecan will be given at the same dose and schedule as the last dose and schedule given during the most recent pre-study irinotecan containing therapy. If the tumour does not show signs of further growth after 12 weeks of treatment, the patient will continue receiving nimotuzumab 400 mg every 2 weeks for up to 18 months or as long as they are getting a benefit from the drug.
Study Oversight
Has Oversight DMC:
True
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?: