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Report for Clinical Trial NCT03227926

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Trial of Rechallenge With Panitumumab Driven by RAS Clonal-mediated Dynamic of Resistance

Open label, single-arm, multiple centers, Phase II trial. The trial has been designed to prove or disprove whether a third line rechallenge with panitumumab can achieve an objective response rate (ORR= CR+PR) of 30% or more in a population of RAS wild type mCRC patients selected on the basis of RAS extended clonal evolution in their plasma.

NCT03227926 Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

1 Interventions

Name: Panitumumab 20 MG/ML Intravenous Solution [VECTIBIX]

Description: Panitumumab 6 mg/kg in 100 cc 0.9% NaCl solution on Day 1 every two weeks by IV administration over 1 hour.
Type: Drug
Group Labels: 1

Trial Phase


Primary Outcomes

Measure: Overall response rate (ORR) to panitumumab according to RECIST v1.1.

Time: Tumor assessments every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Secondary Outcomes

Measure: Progression Free Survival

Time: every 2 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Measure: Overall Survival

Time: every 2 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Measure: Toxicity according to CTCAE version 4.03.

Time: every 2 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Purpose: Treatment

Allocation: Non-Randomized

Sequential Assignment


There is one SNP

SNPs


1 V600E

INCLUSION CRITERIA Molecular Screening - Histologically confirmed diagnosis of metastatic colorectal cancer; - Age ≥ 18 years; - Documented WT RAS exons 2, 3 and 4 (KRas and NRas) and WT BRAF V600E; - Complete or partial response to frontline chemotherapy including anti-EGFR mAb. --- V600E ---



HPO Nodes


HPO: