MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Sur… (NCT01425879) | Clinical Trial Compass
CompletedPhase 2
MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery
United States8 participantsStarted 2011-04
Plain-language summary
This phase II trial is studying how well MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 \[SGPT\] =\…
What they're measuring
1
Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1
Timeframe: Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year