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

NCT01862003 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-08-19

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Cancer Research UK

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University College, London

    lead OTHER

Principal Investigators

  • Daniel Hochhauser, BA, MBBS, MRCP, D.PHIL, FRCP · University College London (UCL) Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-08-02
Completion
2019-08-02

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01862003 on ClinicalTrials.gov