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

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01859182
Phase
PHASE2
Status
Withdrawn

Conditions

  • Adenocarcinoma With Squamous Metaplasia of the Gallbladder
  • Adenocarcinoma 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • selumetinib — DRUG
    Given PO
  • Akt inhibitor MK2206 — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacogenomic studies — OTHER
    Correlative studies
  • quality-of-life assessment — PROCEDURE
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jan 31, 2013
Status verified
Oct 2013
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (selumetinib, Akt inhibitor MK2206)
    Patients receive Akt inhibitor MK-2206 PO on days 1, 8, 15, and 22 (days 8, 15, and 22 of course 1) and selumetinib PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of patients who have a response (PR or CR), assessed by the RECIST v1.1 [ Time Frame: 6 months ]