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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
Group Labels: 1

Treatment (selumetinib, Akt inhibitor MK2206)

Name: Akt inhibitor MK2206

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (selumetinib, Akt inhibitor MK2206)

Name: laboratory biomarker analysis

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (selumetinib, Akt inhibitor MK2206)

Name: pharmacogenomic studies

Description: Correlative studies
Type: Other
Group Labels: 1

Treatment (selumetinib, Akt inhibitor MK2206)

Name: quality-of-life assessment

Description: Ancillary studies
Type: Procedure
Group Labels: 1

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

Allocation: N/A

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: