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Report for Clinical Trial NCT03482362

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

MoTriColor: A Phase II Study of Vinorelbine in Advanced BRAF-like Colon Cancer

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.

NCT03482362 Colon Cancer
MeSH:Colonic Neoplasms
HPO:Colon cancer Neoplasm of the colon

1 Interventions

Name: Vinorelbine Tartrate

Description: Intravenous administration of vinorelbine on day 1 and day 8 in a dose of 30 mg/m2. One treatment cycle is 21 days.
Type: Drug
Group Labels: 2

Cohort A; KRASmt, BRAFwt, BRAF-like CC Cohort B; KRASwt, BRAFmt, BRAF-like CC


Primary Outcomes

Description: This means that by vinorelbine treatment the rate of progression drops to 25%.

Measure: Doubling of progression free survival

Time: 15 months

Secondary Outcomes

Measure: Incidence and severity of adverse events

Time: 15 months

Measure: Overall response rate

Time: 15 months

Measure: Duration of response

Time: 15 months

Measure: Time to response

Time: 15 months

Measure: Overall survival

Time: 15 months

Description: The molecular status will be measured by NGS and IHC in tumor tissue.

Measure: Baseline molecular status (mutation/ expression) in tumor tissue of potential predictive markers of tumor response

Time: 15 months

Description: The molecular status will be measured by NGS and IHC in tumor tissue.

Measure: Gene alterations/expression profiles (i.e. baseline, relapse) in tumor tissue upon progression

Time: 15 months

Other Outcomes

Measure: Overall response rate of vinorelbine in patients with KRAS mutant, BRAF wildtype, BRAF-like colon cancer vs. KRAS wildtype, BRAF mutant, BRAF-like colon cancer.

Time: 15 months

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

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. --- V600E ---



HPO Nodes


HPO: