Cancer Clinical Trial
Official title:
A Phase 1 Study of LY2801653 in Patients With Advanced Cancer
Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to
participants with advanced cancer and to determine any side effects that may be associated
with LY2801653 in this participant population. Efficacy measures will be used to assess the
activity of LY2801653.
Part B- The dose determined in Part A will be used along with efficacy measures to assess the
activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and
neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and
cholangiocarcinoma.
Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that
may be safely given to participants with HNSCC when taken with standard doses of cetuximab
Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that
may be safely given to participants with cholangiocarcinoma when taken with a standard dose
of cisplatin.
Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that
may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus
cisplatin.
Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that
may be safely given to participants with gastric cancer when taken with ramucirumab.
Parts C and D were added to the registration in November, 2013, per protocol amendment. Parts E and F were added to the registration in February, 2015, per protocol amendment. ;
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