MEK and MET Inhibition in Colorectal Cancer

Summary

This trial is designed to try two new cancer drugs together for the first time. The investigators think that they might be effective in some types of bowel cancer. The first part of the trial will see what doses of the two drugs can safely be given together. Once the investigators have identified a suitable dose combination they will look at how effective treatment is in bowel cancers where either the RAS gene is mutated, or MET is over-active. In the trial the investigators will look at samples of blood, skin and tumour to check the drugs are working in the way expected. The trial will take place in three sites in the UK and 5 sites in Europe. The trial is funded as part of the European commission's FP7 program.

Conditions

• Solid Tumor
• Colorectal Cancer

Interventions

DRUG

PF-02341066

PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously

DRUG

PD-0325901

PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.

DRUG

Binimetinib

Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days

Sponsors & Collaborators

• Queen's University, Belfast

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Velindre NHS Trust

  collaborator OTHER_GOV

• University Hospital, Antwerp

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Saint Antoine University Hospital

  collaborator OTHER

• European Georges Pompidou Hospital

  collaborator OTHER

• Pfizer

  collaborator INDUSTRY

• University of Turin, Italy

  collaborator OTHER

• Belfast Health and Social Care Trust

  collaborator OTHER

• Beaumont Hospital

  collaborator OTHER

• European Commission

  collaborator OTHER

• Array BioPharma

  collaborator INDUSTRY

• University of Paris 5 - Rene Descartes

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• Mark R Middleton · Oxford University Hospital NHS Trust

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2018-12-03

Completion

2018-12-03

Countries

• United Kingdom

Study Locations