The purpose of this study was to determine whether ruxolitinib added to capecitabine is effective in improving the overall survival of patients with metastatic pancreatic cancer.
The study consisted of an open-label, safety run-in period that was composed of 1 patient cohort with 9 patients/cohort. This phase of the study determined the safety of the capecitabine/ruxolitinib combination in this patient population. A randomized, double-blind study with two treatment arms was conducted once the safety run-in results from the first part of the study showed that the capecitabine/ruxolitinib combination was safe and additional patients could be treated. All patients have received capecitabine therapy in addition to the ruxolitinib or placebo (Study Drug). Treatment for all patients consisted of repeating 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and the Study Drug was self-administered during the entire 21-day cycle. Treatment cycles continued as long as the regimen was tolerated and the patient did not meet any of the discontinuation criteria. In the event of disease progression, capecitabine therapy was discontinued but the Study Drug could continue to be administered. Subjects who discontinued treatment with the Study Drug continued to be followed to obtain information regarding subsequent treatment regimens and survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
136
Capecitabine starting dose - 2000 mg/m\^2 (1000 mg/m\^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.)
Ruxolitinib starting dose - 15 mg BID (NOTE: Starting dose of randomized study drug may be 10 mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.)
Placebo matching ruxolitinib
Overall Survival
Overall survival was measured as the length of time (in days) between the randomization date and the date of death.
Time frame: Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).
Progression-Free Survival (PFS)
Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.
Objective Response Rate
Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Measured every 4 weeks for duration of study treatment (up to 8 months)
Durable Response Rate
Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.
Time frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)
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Birmingham, Alabama, United States
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Hot Springs, Arkansas, United States
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Burbank, California, United States
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Los Angeles, California, United States
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Santa Monica, California, United States
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Denver, Colorado, United States
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Stamford, Connecticut, United States
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Boynton Beach, Florida, United States
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Fort Myers, Florida, United States
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St. Petersburg, Florida, United States
...and 29 more locations
Summary of Clinical Benefit
A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria: 1. Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status 2. Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation.
Time frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)