Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 8:17 AM
Study NCT ID:
NCT01862003
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Trial of Antagonism of HER in GI Cancer
Sponsor:
University College, London
Organization:
Study Overview
Official Title:
AZD8931, an Inhibitor of EGFR, ERBB2 and ERBB3 Signalling, in Combination With FOLFIRI: a Phase I/II Study to Determine the Importance of Schedule and Activity in Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2019-08
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:
PANTHER
Brief Summary:
Recruitment to phase I of the PANTHER trial is complete.
Phase II, is to evaluate the best overall response rate for AZD8931 + FOLFIRI treatment.
Phase II, is to evaluate the best overall response rate for AZD8931 + FOLFIRI treatment.
Detailed Description:
PANTHER is a registered phase I/phase II trial in patients with recurrent or metastatic colorectal cancer.
The phase II part of the study will be a single arm trial. Patients will receive AZD8931 (an EGFR/ERBB inhibitor) in combination with FOLinic acid, Fluorouracil and IRInotecan (FOLFIRI), Treatment will be given in two-weekly cycles. Phase II's primary objective is to evaluate the Best overall response
The phase II part of the study will be a single arm trial. Patients will receive AZD8931 (an EGFR/ERBB inhibitor) in combination with FOLinic acid, Fluorouracil and IRInotecan (FOLFIRI), Treatment will be given in two-weekly cycles. Phase II's primary objective is to evaluate the Best overall response
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?: