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

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

August 2, 2019

Study Completion Date

August 2, 2019

Conditions
Metastatic Colorectal CancerRecurrent Colorectal Cancer
Interventions
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.

Trial Locations (4)

Unknown

Barts Health NHS Trust, London

Guy's and St Thomas' NHS Foundation Trust, London

University College London Hospital NHS Foundation Trust, London

The Christie NHS Foundation Trust, Manchester

Sponsors
All Listed Sponsors
collaborator

Cancer Research UK

OTHER

collaborator

AstraZeneca

INDUSTRY

collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

lead

University College, London

OTHER