SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01801904

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

NCT01801904 Metastatic Colorectal Cancer
MeSH: Colorectal Neoplasms
HPO: Neoplasm of the large intestine

1 Interventions

Name: Panitumumab

Description: 6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity

Type: Drug

Panitumumab


Primary Outcomes

Description: progression of disease within 2 months from registration according to RECIST criteria, and death for any cause within 2 months from registration

Measure: number of patients alive and without disease progression

Time: 2 months

Secondary Outcomes

Description: Response assessed per patients at weeks 8,16,24,32,40 and every 3 months thereafter, using RECIST criteria

Measure: response rate

Time: up to 40 weeks

Measure: progression free survival

Time: 9 months

Measure: overall survival

Time: one year

Description: worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 3) per patient

Measure: worst grade toxicity per patient

Time: every 2 weeks for up to 6 months

Other Outcomes

Description: exploratory analysis of tumor-tissue for biological or genomic determinants of outcome of BRAF and P13K mutation status, EGFR and PTEN expression status

Measure: gene expression on tumor tissue

Time: one year

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 P13K

exploratory analysis of tumor-tissue for biological or genomic determinants of outcome of BRAF and P13K mutation status, EGFR and PTEN expression status. --- P13K ---



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