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Axitinib Monotherapy With Early Dynamic Contrast Enhanced Ultrasound Monitoring in Chemorefractory Third Line Metastatic Colorectal Cancer

NCT04355156 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-04-16

Study results available
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Summary

This is a study of Axitinib versus placebo as monotherapy for people with colorectal cancer who have liver metastases and who have relapsed within 6 months of their last chemotherapy regime. The research will also look at the potential of CEHPI (Contrast Enhanced Hepatic Perfusion Index) reduction, a technique developed for this research to measure the changes in how the blood vessels pump blood into the different liver metastases (tumours) and therefore to assess and predict response to treatment.

Conditions

Interventions

DRUG

Axitinib

* All patients randomised to this arm will receive 3mg BD, and increased at 2 weeks to 5mg BD * Outpatient monitoring at 2 week intervals for a minimum of 8 weeks, with 2 weekly liver contrast ultrasound for assessment of differential blood supply (CEHPI) * At 8 weeks, after tumour CT RECIST assessments, responders will continue monotherapy. In non-responders, those with disease progression, monotherapy can be continued if patient chooses to continue and if tolerated

DRUG

Placebo

* All patients receiving placebo will receive tablets to take BD * Outpatient monitoring at 2 week intervals for a minimum of 8 weeks, with 2 weekly liver contrast ultrasound for assessment of differential blood supply (CEHPI)

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-17
Primary Completion
2019-02-22
Completion
2019-02-22
FDA Drug
Yes

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 NCT04355156 on ClinicalTrials.gov