Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403052
Status:
TERMINATED
Last Update Posted:
2019-04-16
First Post:
2006-11-21
Brief Title:
A Study of 1018 Immunostimulatory Sequence ISS Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
Sponsor:
Dynavax Technologies Corporation
Organization:
Dynavax Technologies Corporation
Study Overview
Official Title:
Phase 1 Study of the Combination of 1018 ISS Irinotecan and Cetuximab in Patients With Metastatic Colorectal Cancer Previously Treated With a Fluoropyrimidine Oxaliplatin or Irinotecan With or Without Bevacizumab
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objectives of this study are to establish a safe tolerable and active dose of 1018 ISS administered in combination with irinotecan and cetuximab in patients with metastatic colorectal cancer Other objectives also include determining tumor response time to disease progression and overall survival in treated patients
Detailed Description:
This is a Phase I open-label study of escalating dose levels of 1018 ISS in combination with irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer Approximately 15 patients will be treated The objectives of this study are to establish a safe tolerable and active dose of 1018 ISS determine tumor response time to disease progression and overall survival in treated patients
The safety and tolerability of 1018 ISS will be evaluated by periodic laboratory assessments physical examinations and compilation of adverse events
Once study patients have been consented screened and assigned to one of the dose levels of 1018 ISS patients will receive two 4 week cycles of 1018 ISS therapy plus irinotecan every other week and cetuximab weekly Irinotecan and cetuximab will continue thereafter until disease progression unacceptable toxicity or until the patient refuses treatment
The safety and tolerability of 1018 ISS will be evaluated by periodic laboratory assessments physical examinations and compilation of adverse events
Once study patients have been consented screened and assigned to one of the dose levels of 1018 ISS patients will receive two 4 week cycles of 1018 ISS therapy plus irinotecan every other week and cetuximab weekly Irinotecan and cetuximab will continue thereafter until disease progression unacceptable toxicity or until the patient refuses treatment
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