MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery

Completed · Phase 2

Conditions studied: Advanced Adult Hepatocellular Carcinoma, Localized Non-Resectable Adult Liver Carcinoma, Recurrent Adult Liver Carcinoma, Recurrent Gallbladder Carcinoma, Stage IV Distal Bile Duct Cancer, Stage IV Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Carcinoma, Unresectable Gallbladder Carcinoma

In brief

This phase II trial is studying how well MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery.

Key facts

Study ID

NCT01425879

Run by

National Cancer Institute (NCI)

People needed

8

Starts

2011-04-01

Expected to finish

2014-05-01

Last updated by the study team

2016-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically confirmed biliary tract carcinoma that is surgically unresectable
• Cytological confirmation is not allowed on this study, as tissue is needed for correlative science analysis
• Either fresh-frozen tissue (FFT) or paraffin-embedded tissue blocks (PETB) will be required from patients before enrolling on this study
• No biopsies will be required unless there is insufficient tissue or if the PETB available is more than 12 months old
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with spiral CT scan (CT scan slice thickness no greater than 5 mm)
• Malignant lymph nodes will be considered measurable if they are ≥ 15 mm in short axis
• Patients must have received one prior therapy for metastatic disease
• No prior Akt inhibitors allowed
• Patients with known brain metastases should be excluded from this clinical trial
• Life expectancy greater than 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) =<2 (Karnofsky >= 60%)
• Leukocytes >= 3,000/mcL
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelet count >= 100,000/mcL
• Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT] =< 2.5 x IULN
• Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (measured or calculated using the Cockroft-Gualt formula)
• Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• Not pregnant or nursing
• Able to swallow oral tablets
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Akt Inhibitor MK2206 (MK2206) or other agents used in the study
• Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial
• Cardiovascular: baseline QTcF > 450 msec (male) or QTcF > 470 msec (female) will exclude patients from entry on study
• Patients with clinically significant bundle branch block or pre-existing clinically significant bradycardia will be excluded from the study
• No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Emory University/Winship Cancer Institute — Atlanta, Georgia, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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