SNPMiner Trials by Shray Alag

SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT00553332

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 2 Study of AZD6244 in Biliary Cancers

This phase II trial is studying how well selumetinib works in treating patients with biliary cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT00553332 Liver and Intrahepatic Biliary Tract Cancer Recurrent Extrahepatic Bile Duct Cancer Unresectable Extrahepatic Bile Duct Cancer
MeSH: Biliary Tract Neoplasms Bile Duct Neoplasms Cholangiocarcinoma
HPO: Biliary tract neoplasm Cholangiocarcinoma

2 Interventions

Name: selumetinib

Description: Given orally

Type: Drug

Treatment (enzyme inhibitor therapy)

Name: laboratory biomarker analysis

Description: Correlative studies

Type: Other

Treatment (enzyme inhibitor therapy)

Primary Outcomes

Description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Measure: Objective Response Rate (CR and PR)

Time: Every 8 weeks

Secondary Outcomes

Description: Toxicitity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0

Measure: Toxicity Profile of AZD6244

Time: From the time of first treatment with AZD6244, assessed up to 4 weeks

Description: Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Measure: Median Progression Free Survival for Patients

Time: Up to 6 months

Measure: Overall Survival

Time: Up to 12 months

Measure: RAS/RAF/MEK/ERK Signaling Pathway Activation

Time: At baseline

Description: Measure the proteins levels of RAS/RAF/MEK/ERK signaling pathway activation to AZD6244

Measure: Protein Levels of RAS/RAF/MEK/ERK Signaling Pathway Activation

Time: At baseline

Purpose: Treatment

Single Group Assignment

There is one SNP


1 V600E

To genotype tumors for the presence of RAS mutations (i.e., NRAS, KRAS, HRAS) and BRAF mutations (e.g., V600E) in biliary tumor samples from these patients. --- V600E ---

HPO Nodes

Biliary tract neoplasm
Genes 8
Genes 3