Study of Ruxolitinib in Pancreatic Cancer Patients (RECAP)
Metastatic Pancreatic Adenocarcinoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized Phase 2 Study of Ruxolitinib Efficacy and Safety in Combination With Capecitabine for Subjects With Recurrent or Treatment Refractory Metastatic Pancreatic Cancer (The RECAP Trial)|
- Overall Survival [ 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). ] [ Designated as safety issue: No ]Overall survival was measured as the length of time (in days) between the randomization date and the date of death.
- Progression-Free Survival (PFS) [ 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. ] [ Designated as safety issue: No ]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
- Objective Response Rate [ Time Frame: Measured every 4 weeks for duration of study treatment (up to 8 months) ] [ Designated as safety issue: No ]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.
- Durable Response Rate [ Time Frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) ] [ Designated as safety issue: No ]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.
- Summary of Clinical Benefit [ Time Frame: Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months) ] [ Designated as safety issue: No ]
A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:
- 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
- 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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||October 2016|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: Capecitabine and ruxolitinib||
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.)Drug: Ruxolitinib
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 Comparator: Capecitabine and placebo||
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.)Drug: Placebo
Placebo matching ruxolitinib
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423604
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|Study Director:||William Williams, MD||Incyte Corporation|