Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that includes identifying the MTD of itacitinib (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 and Part 2A: This phase will explore the safety and tolerability of the MTD or PAD of itacitinib (INCB039110) when administered in combination with gemcitabine and nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Fayetteville, Arkansas, United States
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Southington, Connecticut, United States
Safety and tolerability of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events
Time frame: 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).
Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for itacitinib (INCB039110) in the treatment regimens administered
Time frame: Each cohort will be observed for a minimum of 28 days.
Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110)
Time frame: Baseline up to 6 months.
Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.
Time frame: Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).
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Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Lake Success, New York, United States
Unnamed facility
Philadelphia, Pennsylvania, United States