NCT01862003

Phase I/II Trial of Antagonism of HER in GI Cancer

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Metastatic Colorectal Cancer
• Recurrent Colorectal Cancer

Interventions

Type	Name	Description
DRUG	AZD8931	160 mg AZD8931 tablets, twice daily on days 1 - 4 of each 2-weekly cycle
DRUG	Irinotecan	180 mg/m2 (IV infusion) of Irinotecan on day 1 of each 2-weekly cycle - can be given simultaneously with Folinic acid.
DRUG	Folinic Acid	350 mg (IV infusion) of Folinic acid on day 1 of each 2-weekly cycle - can be given simultaneously with Irinotecan.
DRUG	Fluorouracil	400 mg/m2 (IV bolus) of Fluorouracil on day 1 of each 2-weekly cycle, to be given after completion of Irinotecan and Folinic acid.
DRUG	Fluorouracil	2400 mg/m2 (IV) continuous infusion of Fluorouracil given over 46 hours - infusion to start after 5FU bolus.

Timeline

• Start date: 2014-05-01
• Primary completion: 2019-08-02
• Completion: 2019-08-02
• First posted: 2013-05-24
• Last updated: 2019-08-19

Locations

4 sites across 1 country: United Kingdom