A Phase 1B Study of the Safety and Tolerability of INCB039110 in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that
includes the maximum tolerated dose of INCB039110 (within a defined pharmacologic range) in
combination with doses of gemcitabine and nab-paclitaxel that have established safety and
tolerability in subjects with advanced or metastatic solid tumors.
Study Part 2: This phase will explore the safety and clinical activity of the regimen
identified in Part 1, in subjects with advanced or metastatic pancreatic cancer.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of the treatment regimen as measured by the number of participants with adverse events.
Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit (approximately 6 months).
William V. Williams, M.D.
United States: Food and Drug Administration
|Phoenix, Arizona 85012|