Selumetinib in Treating Patients With Biliary Cancer That Cannot Be Removed By Surgery

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00553332
Phase
PHASE2
Status
Completed

Conditions

  • Liver and Intrahepatic Biliary Tract Cancer
  • Recurrent Extrahepatic Bile Duct Cancer
  • Unresectable Extrahepatic Bile Duct Cancer

Eligibility Criteria

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

Interventions

  • selumetinib — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Nov 30, 2007
Status verified
Mar 2016
Primary completion
Jan 31, 2013
Completion
Jan 31, 2013

Study Design

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

Arms

  • Experimental: Treatment (enzyme inhibitor therapy)
    Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (CR and PR) [ Time Frame: Every 8 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
University of Michigan Cancer Center (UMCC) Research BaseAnn ArborMichigan48109-0352-
Wayne State UniversityDetroitMichigan48202-
University of North CarolinaChapel HillNorth Carolina27599-
Ohio State University Medical CenterColumbusOhio43210-
Vanderbilt UniversityNashvilleTennessee37232-

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FLEmory University· Atlanta, GAUniversity of Michigan Cancer Center (UMCC) Research Base· Ann Arbor, MIWayne State University· Detroit, MIUniversity of North Carolina· Chapel Hill, NCOhio State University Medical Center· Columbus, OH