Imatinib as Pre-operative Anti-Colon Cancer Targeted Therapy

• Status: Terminated
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

In this proof-of-concept trial the investigators will study the effects of imatinib treatment on the biology of mesenchymal-type colon cancers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborators: Erasmus Medical Center; Hubrecht Institute; Meander Medical Center
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

1. Male or female aged ≥18 years

2. Histologically proven adenocarcinoma of the colon;

3. Completed cancer staging with CT-abdomen and CT-thorax/X-thorax according to hospital's standard of care;

4. Confirmed eligibility for surgery with curative intent as deemed by the hospital's multidisciplinary board (MDB) review;

5. An intratumoural gene expression profile of PDGFR-α, PDGFR-β, PDGF-C and KIT, indicative of the mesenchymal phenotype, according to our diagnostic RT-qPCR test (i.e. more than 50% chance of having the mesenchymal phenotype);

6. Minimum of four properly stored pre-treatment biopsies for gene expression analysis/ELISA;

7. WHO performance status 0 or 1;

8. Adequate haematology status and organ function, defined as:

• Normal creatinine clearance (≥60 ml/min (MRDR))

• ALAT within 2.5x upper limit of normal (ULN)

• PT-INR < 1.5

• Leukocytes > 1,5*10^9/L; Hb > 6.0 mmol/L; platelets > 100*10^9/L

9. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests;

10. Written informed consent.

Exclusion Criteria:

1. The presence of synchronous distant metastases;

2. Current hospital standard of care dictates that subject should undergo any neoadjuvant therapy;

3. Concurrent participation in another clinical trial using any medicinal product, or participation in such a trial in the period of three months prior to the current trial;

4. Women who are pregnant, plan to become pregnant or are lactating during the study or for up to 30 days after the last dose of imatinib;

5. Known HIV or Hepatitis B/C infection;

6. Known symptomatic congestive heart failure;

7. Co-morbidity requiring concomitant treatment with drugs that act as strong inducers of CYP3A4 or with drugs with a narrow therapeutic range influenced by imatinib