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.
Name: selumetinib
Description: Given POType: DrugTreatment (selumetinib, Akt inhibitor MK2206)
Name: Akt inhibitor MK2206
Description: Given POType: DrugTreatment (selumetinib, Akt inhibitor MK2206)
Name: laboratory biomarker analysis
Description: Correlative studiesType: OtherTreatment (selumetinib, Akt inhibitor MK2206)
Name: pharmacogenomic studies
Description: Correlative studiesType: OtherTreatment (selumetinib, Akt inhibitor MK2206)
Name: quality-of-life assessment
Description: Ancillary studiesType: ProcedureTreatment (selumetinib, Akt inhibitor MK2206)
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 monthsDescription: 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 weeksDescription: 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 weeksSingle Group Assignment
There is one SNP
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 ---