CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 82 enrolled
Drug / intervention
PF-02341066 +2 moredrug
Likely dose
PF-02341066 250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02510001
NCT02510001Phase 1Completed
CompareCT.gov

A Sequential Phase I Study of MEK1/2 Inhibitors PD-0325901 or Binimetinib Combined With cMET Inhibitor PF-02341066 in Patients With RAS Mutant and RAS Wild Type (With Aberrant c-MET) Colorectal Cancer

University of Oxford·interventional·Posted Jul 28, 2015·Updated Jul 13, 2021

In Brief

A Phase 1 clinical trial evaluating PF-02341066, PD-0325901, and 1 other intervention for Solid Tumor and Colorectal Cancer. Completed, enrolled 82 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor, Colorectal Cancer
CountriesUnited Kingdom
CollaboratorsQueen's University, Belfast, Oxford University Hospitals NHS Trust, Velindre NHS Trust, University Hospital, Antwerp, Hospital Vall d'Hebron, Saint Antoine University Hospital, European Georges Pompidou Hospital, Pfizer, University of Turin, Italy, Belfast Health and Social Care Trust, Beaumont Hospital, European Commission, Array BioPharma, University of Paris 5 - Rene Descartes

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 28, 2015
Enrollment StartNov 1, 2014
Primary CompletionDec 3, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.9 years ago

Interventions

PF-02341066drug

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

PD-0325901drug

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.

Binimetinibdrug

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