This is a phase II study (the second stage of testing a new drug or new drug combinations) to see how useful two different schedules of study drug selumetinib with cisplatin and gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer. Selumetinib, an oral drug which plays an important role in the regulation of cell growth (MEK 1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. Selumetinib has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs that work by damaging DNA in tumor cells so that they are unable to grow and divide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Change in tumor size in millimetres
Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time frame: 10 weeks post initiation of therapy
Number of participants with objective response and/or stable disease
Time frame: 6 months post initiation of therapy
Percentage of patients without progressive disease
Time frame: 10 weeks post initiation of therapy
Progression-free survival in months
Time frame: Enrollment to disease progression or death
Overall survival in months
Time frame: Time from enrollment to date of death
Total incidence of adverse events
Time frame: 2 years
Total rate of grade 3 and 4 toxicities
Time frame: 2 years
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