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
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:Neoplasm of the large intestine
Genes 71
FOXE1 PMS1 CDKN2A KRAS MST1 TGFBR2 STK11 MSH6 TCF4 BMPR1A PMS2 KLLN MLH3 DLC1 NRAS BRCA1 BRCA2 PDGFRA DOCK8 PIK3CA GPR35 POLD1 NTHL1 POLE SRC BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 AKT1 RPS19 RPS20 HABP2 MSH2 FGFR3 MSH3 KEAP1 GREM1 MINPP1 SEMA4A CTNNB1 DCC BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM DICER1 RNF43 PALLD EP300 PALB2 SEC23B MUTYH SDHA TP53 SDHB SDHC SDHD AXIN2 SMAD4 FAN1 hr>