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Report for Clinical Trial NCT01801904

Developed by Shray Alag, 2020.
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 120
FLCN SDHC MLH1 PMS2 APC EPCAM SDHC PALLD SRC BUB1 APC GREM1 NTHL1 PMS1 PTEN SDHB MSH6 APC KIT SDHD KRAS BMPR1A FAN1 CTNNB1 MSH3 POLD1 KRAS RNF43 KEAP1 DICER1 DLC1 BMPR1A MSH2 MSH6 PIK3CA CDKN2A FGFR3 BMPR1A MUTYH PIK3CA BMPR1A EP300 FOXE1 ENG SMAD7 AXIN2 CHEK2 MLH1 RPS20 BRCA1 RPS19 PRKAR1A APC GPR35 MLH1 AKT1 POLE SMAD4 KIT TP53 TRIP13 COL14A1 MDM2 SMAD4 POLE BRCA2 AKT1 MSH6 HABP2 NRAS MUTYH BUB1B DOCK8 TGFBR2 STK11 AXIN2 EPCAM BUB3 DCC AXIN2 TCF4 KLLN MSH2 APC TP53 SEC23B PTEN TGFBR2 SEMA4A POLD1 PIK3CA PDGFRA MINPP1 APC SH3KBP1 BMPR1A TP53 BUB1 AAGAB SMAD4 BMPR1A MST1 MLH3 MSH2 PALB2 FLCN SDHA PMS2 SDHB BUB1B MSH2 MLH1 CEP57 MLH3 TP53 PTPRJ PMS1 APC CDKN2A APC