Clinical trial · Interventional
Imatinib as Pre-operative Anti-Colon Cancer Targeted Therapy
Targeted Therapy With Imatinib for Treatment of Poor Prognosis Mesenchymal-type Resectable Colon Cancer: a Proof-of-concept Study in the Preoperative Window Period.
NCT02685046CI-TRIAL-00041127ImPACCTterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual rate
Summary
Brief summary (as posted)
In this proof-of-concept trial the investigators will study the effects of imatinib treatment on the biology of mesenchymal-type colon cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Subjects will be treated with the medicinal product imatinib, which will be administered orally in tablets of 400mg, once per day, during two weeks prior to tumor resection.
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
- Effects of treatment on the mesenchymal gene expression profile
- timeFrame
- period from diagnostic colonoscopy until surgical resection (~5 weeks)
- description
- To assess the extent of change in the mesenchymal phenotype, gene expression arrays will be generated from pre- and post-treatment tissue samples and the expression of genes associated with the poor-prognosis mesenchymal subtype will be compared.
Secondary outcomes (7)
- measure
- Extent of targeted inhibition of PDGFR and KIT phosphorylation in cancer cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDUbink I, Bloemendal HJ, Elias SG, Brink MA, Schwartz MP, Holierhoek YCW, Verheijen PM, Boerman AW, Mathijssen RHJ, de Leng WWJ, de Weger RA, van Grevenstein WMU, Koopman M, Lolkema MP, Kranenburg O, Borel Rinkes IHM. Imatinib treatment of poor prognosis mesenchymal-type primary colon cancer: a proof-of-concept study in the preoperative window period (ImPACCT). BMC Cancer. 2017 Apr 19;17(1):282. doi: 10.1186/s12885-017-3264-y. PMID 28424071