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Selumetinib and Akt Inhibitor MK-2206 in Treating Patients With Refractory or Advanced Gallbladder or Bile Duct Cancer That Cannot Be Removed By Surgery

NCT01859182 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-09-09

No results posted yet for this study

Summary

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.

Conditions

  • 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

Interventions

DRUG

selumetinib

Given PO

DRUG

Akt inhibitor MK2206

Given PO

OTHER

laboratory biomarker analysis

Correlative studies

OTHER

pharmacogenomic studies

Correlative studies

PROCEDURE

quality-of-life assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tanios Bekaii-Saab · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-05-31
Completion
2013-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01859182 on ClinicalTrials.gov