This study will evaluate the safety, tolerability, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with capecitabine and oxaliplatin in adults with relapsed/refractory metastatic pancreatic ductal adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Momelotinib (MMB) tablet(s) administered orally once or twice daily
Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment
Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle.
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Tennessee Oncology
Nashville, Tennessee, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Incidence of dose limiting toxicities
Dose limiting toxicities refer to toxicities experienced during the first 21 days of treatment that have been judged to be clinically significant and at least possibly related to study treatment.
Time frame: Up to 21 days
Incidence of adverse events, assessment of clinical laboratory test findings, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements
This composite endpoint will measure the safety profile of momelotinib.
Time frame: Up to 2 years
Overall response rate
Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: Up to 2 years
Overall survival
Overall survival (OS) is defined as the interval from first dose date of study drug to death from any cause.
Time frame: Up to 2 years
Progression-free survival
Progression-free survival (PFS) is defined as the interval from first dose date of study drug to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on RECIST criteria v1.1.
Time frame: Up to 2 years
Pharmacokinetic (PK) profile of momelotinib (MMB)
This composite endpoint will measure the plasma PK profile of momelotinib (MMB). The following parameters will be measured, where applicable: * Cmax: maximum observed concentration of drug in plasma * Ctau: observed drug concentration at the end of the dosing interval * AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)
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Time frame: Predose and postdose on Day 15