SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT03227926
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
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.
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
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
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