drugset
drugset / Trial / NCT03482362

Vinorelbine in Advanced BRAF-like Colon Cancer

NCT03482362 ↗

Phase 2 Completed 1 enrolled The Netherlands Cancer Institute Agendia · collabAzienda Ospedaliera Niguarda Cà Granda · collabCatalan Institute of Health · collabEli Lilly and Company · collabEuropean Organisation for Research and Treatment of Cancer - EORTC · collabFundación para la Investigación del Hospital Clínico de Valencia · collabUniversitaire Ziekenhuizen KU Leuven · collabUniversity of Campania Luigi Vanvitelli · collabUniversity of Turin, Italy · collabVall d'Hebron Institute of Oncology · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Vecchione et al showed that suppression of RANBP2 results in mitotic defects only in BRAF-like colon cancer (CC) cells, which leads to cell death. Mechanistically, RANBP2 silencing reduces microtubule outgrowth from the kinetochores, thereby inducing spindle perturbations, providing an explanation for the observed mitotic defects. Vinorelbine mimics RANPB2 silencing in BRAF-like and BRAFV600E CC cell lines. These preclinical data represent a strong rationale to also explore the anti-tumor activity of vinorelbine in patients with advanced BRAF-like (both BRAFm and BRAF wild type) CC. Tumors having this gene signature are referred to as "BRAF-like" and have a similar poor prognosis irrespective of the presence of BRAF(V600E) mutation. Since vinorelbine is standard of care in advanced breast and NSCLC, there is ample experience with the dose and schedule as well as with the safety profile and supportive measures required to prevent side-effects.

Timeline

Start
2018-03-01
Primary completion
2020-03-17
Completion
2020-03-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Vinorelbine Small molecule 30 mg/m2 Intravenous

Indications

colon carcinoma