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Brief Title: Vinorelbine in Advanced BRAF-like Colon Cancer
Official Title: MoTriColor: A Phase II Study of Vinorelbine in Advanced BRAF-like Colon Cancer
Study ID: NCT03482362
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, Netherlands
Name: N Steeghs, MD, PhD
Affiliation: NKI-AvL
Role: PRINCIPAL_INVESTIGATOR
Name: J Tabernero, Prof
Affiliation: VHIO
Role: PRINCIPAL_INVESTIGATOR
Name: R Salazar, MD, PhD
Affiliation: ICO
Role: PRINCIPAL_INVESTIGATOR
Name: R Bernards, Prof
Affiliation: Agendia
Role: PRINCIPAL_INVESTIGATOR
Name: S Siena, Prof
Affiliation: ONCG
Role: PRINCIPAL_INVESTIGATOR
Name: A Cervantes, Prof
Affiliation: INCLIVA
Role: PRINCIPAL_INVESTIGATOR
Name: F Ciardiello, Prof
Affiliation: INCLIVA
Role: PRINCIPAL_INVESTIGATOR
Name: A Bardelli, Prof
Affiliation: UNITO
Role: PRINCIPAL_INVESTIGATOR
Name: S Tejpar, Prof
Affiliation: UZ Leuven
Role: PRINCIPAL_INVESTIGATOR