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Report for Clinical Trial NCT01859182

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicenter Phase II Study of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Patients With Refractory Advanced Biliary Cancers

This phase II trial studies how well selumetinib and Akt inhibitor MK-2206 work in treating patients with refractory or advanced gallbladder or bile duct cancer that cannot be removed by surgery. Selumetinib and Akt inhibitor MK-2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT01859182 Adenocarcinoma of the Gallbladder Adenocarcinoma With Squamous Metaplasia of the Gallbladder Adult Primary Cholangiocellular Carcinoma Advanced Adult Primary Liver Cancer Cholangiocarcinoma of the Extrahepatic Bile Duct Localized Unresectable Adult Primary Liver Cancer Metastatic Extrahepatic Bile Duct Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Stage II Gallbladder Cancer Stage IIIA Gallbladder Cancer Stage IIIB Gallbladder Cancer Stage IVA Gallbladder Cancer Stage IVB Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer
MeSH: Adenocarcinoma Liver Neoplasms Cholangiocarcinoma Gallbladder Neoplasms Bile Duct Neoplasms Metaplasia
HPO: Cholangiocarcinoma Neoplasm of the gallbladder Neoplasm of the liver

5 Interventions

Name: selumetinib

Description: Given PO

Type: Drug

Treatment (selumetinib, Akt inhibitor MK2206)

Name: Akt inhibitor MK2206

Description: Given PO

Type: Drug

Treatment (selumetinib, Akt inhibitor MK2206)

Name: laboratory biomarker analysis

Description: Correlative studies

Type: Other

Treatment (selumetinib, Akt inhibitor MK2206)

Name: pharmacogenomic studies

Description: Correlative studies

Type: Other

Treatment (selumetinib, Akt inhibitor MK2206)

Name: quality-of-life assessment

Description: Ancillary studies

Type: Procedure

Treatment (selumetinib, Akt inhibitor MK2206)


Primary Outcomes

Description: Calculated with corresponding 95% binomial confidence intervals.

Measure: Proportion of patients who have a response (PR or CR), assessed by the RECIST v1.1

Time: 6 months

Secondary Outcomes

Description: Frequency and severity of adverse events and tolerability of the regimen in each of the patient groups will be collected and summarized by descriptive statistics.

Measure: Frequency and severity of adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

Time: Up to 4 weeks

Description: Changes in overall quality of life will be explored in relation to severe toxicity incidence and in particular to incidence of cachexia. Graphical analyses will be used to assess patterns in these patient reported outcomes in relation to the clinical and tolerability outcomes of incidence.

Measure: Changes in QOL evaluated using the Functional Assessment of Cancer Therapy - General (FACT-G)

Time: Baseline to 8 weeks

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V600E

To determine the presence of genetic mutations of phosphatidylinositol 3 kinase (PI3K)/protein kinase B (Akt) and mitogen-activated protein kinase (MAPK) signaling pathway genes (other than v-raf murine sarcoma viral oncogene homolog [BRAF] V600E) relevant to biliary cancer and how these correlate with and may predict objective response to treatment with AZD6244 hydrogen sulfate and MK-2206. --- V600E ---



HPO Nodes


HPO:
Cholangiocarcinoma
Genes 3
MST1 TCF4 GPR35
Neoplasm of the gallbladder
Genes 5
PSAP MST1 TCF4 ARSA GPR35
Neoplasm of the liver
Genes 132
TTC37 REST GPC3 TMEM67 AHCY HNF1A TRIP13 IGF2R HFE MLH1 PMS2 APC INS ABCC8 PALLD POU2AF1 BRCA2 HMBS HBB STAT6 MSH6 APC SLC25A13 RASGRP1 UROD INPP5E TP53 PRKCD KRAS SLC37A4 FAN1 SETBP1 NEUROD1 SKIV2L RPGRIP1L FAS KRAS WT1 MSH2 HMBS G6PC SPRTN PAX4 PIK3CA RELA SERPINA1 PDX1 TNFSF15 ATP7B ABCB11 RPS20 BRCA1 HFE H19 PRKAR1A TRIM28 KLF11 APC F5 GPR35 MLH1 APC BLK WT1 CTNNB1 CASP10 H19-ICR CEL GPC4 TRIM28 JAG1 HNF1A CASP8 HFE BMP2 BRCA2 MSH6 POU6F2 KCNQ1OT1 H19 NAB2 GCK KCNQ1 SMPD1 HNF4A FAH EPCAM AXIN1 TCF4 MSH2 APC KCNJ11 IL12A TGFBR2 SEMA4A JAK2 DIS3L2 FAS APPL1 APC BMPR1A TP53 FAH CDKN1C SPIB SMAD4 PHKG2 HBB C11ORF95 MST1 MLH3 GPC3 PALB2 IGF2 SLC37A4 PHKA2 PDGFRL SETBP1 IGF2 FASLG IL12RB1 SLC25A13 IRF5 MET PIK3CA MMEL1 H19 PMS1 CDKN2A CC2D2A TJP2 TNPO3