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Study of Ruxolitinib in Pancreatic Cancer Patients (RECAP)

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ClinicalTrials.gov Identifier: NCT01423604
Recruitment Status : Completed
First Posted : August 26, 2011
Results First Posted : August 29, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Capecitabine
Drug: Ruxolitinib
Drug: Placebo
Enrollment 136
Recruitment Details The open-label, safety run-in (1 cohort) was designed to confirm the safety of the combination of ruxolitinib and capecitabine in subjects with advanced or metastatic adenocarcinoma of the pancreas. The double-blind portion was 2 treatment groups randomized 1:1: ruxolitinib plus capecitabine or matching placebo plus capecitabine.
Pre-assignment Details  
Arm/Group Title Ruxolitinib Placebo
Hide Arm/Group Description

Part 1: Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) + ruxolitinib 15 mg BID.

Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).

Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Period Title: Safety Run-In
Started 9 0
Completed 0 0
Not Completed 9 0
Reason Not Completed
Adverse Event             3             0
Death             1             0
Physician Decision             1             0
Disease progression             3             0
Patient decision             1             0
Period Title: Randomized
Started 64 63
Completed 1 [1] 0
Not Completed 63 63
Reason Not Completed
Adverse Event             4             10
Death             1             0
Physician Decision             16             13
Other - unspecified             37             31
Patient decision             5             9
[1]
As of 07August2015, 1 subject was receiving treatment in the randomized portion.
Arm/Group Title Ruxolitinib - Safety Run-In Ruxolitinib Placebo Total
Hide Arm/Group Description Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]) + ruxolitinib at 15 mg BID. Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). Total of all reporting groups
Overall Number of Baseline Participants 9 64 63 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 64 participants 63 participants 136 participants
61.6  (9.4) 65.7  (9.3) 66.3  (9.8) 66.0  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 64 participants 63 participants 136 participants
Female
5
  55.6%
23
  35.9%
29
  46.0%
57
  41.9%
Male
4
  44.4%
41
  64.1%
34
  54.0%
79
  58.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 64 participants 63 participants 136 participants
Hispanic or Latino
0
   0.0%
1
   1.6%
5
   7.9%
6
   4.4%
Not Hispanic or Latino
9
 100.0%
62
  96.9%
58
  92.1%
129
  94.9%
Unknown or Not Reported
0
   0.0%
1
   1.6%
0
   0.0%
1
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 64 participants 63 participants 136 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  11.1%
0
   0.0%
1
   1.6%
2
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  33.3%
9
  14.1%
6
   9.5%
18
  13.2%
White
5
  55.6%
54
  84.4%
54
  85.7%
113
  83.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.6%
2
   3.2%
3
   2.2%
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 9 participants 64 participants 63 participants 136 participants
171.67  (14.11) 171.29  (11.93) 168.27  (10.25) 169.78  (11.18)
[1]
Measure Description: Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 9 participants 64 participants 63 participants 136 participants
75.051  (17.317) 75.014  (21.914) 69.299  (16.260) 72.156  (19.427)
[1]
Measure Description: Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)
Body mass index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 9 participants 64 participants 63 participants 136 participants
25.3  (4.209) 25.354  (6.332) 24.243  (4.237) 24.789  (5.394)
[1]
Measure Description: Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)
Body surface area   [1] 
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 9 participants 64 participants 63 participants 136 participants
1.869  (0.287) 1.863  (0.297) 1.791  (0.248) 1.827  (0.275)
[1]
Measure Description: Treatment Group Ruxolitinib (N = 60); Placebo (N = 60)
1.Primary Outcome
Title Overall Survival
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.
Arm/Group Title Ruxolitinib Placebo
Hide Arm/Group Description:
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Overall Number of Participants Analyzed 64 63
Median (95% Confidence Interval)
Unit of Measure: days
136.5
(95.0 to 196.0)
129.5
(71.0 to 179.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0494
Comments One-sided p-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.733
Confidence Interval (2-Sided) 95%
0.506 to 1.061
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ruxolitinib, Placebo
Comments Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) > 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0081
Comments One-sided p-value.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.502
Confidence Interval (2-Sided) 95%
0.281 to 0.888
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.
Arm/Group Title Ruxolitinib Placebo
Hide Arm/Group Description:
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Overall Number of Participants Analyzed 64 63
Median (95% Confidence Interval)
Unit of Measure: days
51.0
(42.0 to 84.0)
46.0
(41.0 to 70.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1340
Comments Two-sided p-value.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Efron approximation of hazard ratio
Estimated Value 0.750
Confidence Interval (2-Sided) 95%
0.513 to 1.094
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.
Arm/Group Title Ruxolitinib Placebo
Hide Arm/Group Description:
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Overall Number of Participants Analyzed 64 63
Measure Type: Number
Unit of Measure: percentage of participants
Overall response 7.8 1.6
Complete response 1.6 0.0
Partial response 6.3 1.6
4.Secondary Outcome
Title Durable Response Rate
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.
Arm/Group Title Ruxolitinib Placebo
Hide Arm/Group Description:
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Overall Number of Participants Analyzed 64 63
Measure Type: Number
Unit of Measure: percentage of participants
7.8 0.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0236
Comments [Not Specified]
Method Pearson’s chi-square test
Comments [Not Specified]
5.Secondary Outcome
Title Summary of Clinical Benefit
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.
Arm/Group Title Ruxolitinib Placebo
Hide Arm/Group Description:
Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
Overall Number of Participants Analyzed 64 63
Measure Type: Number
Unit of Measure: percentage of participants
Subjects with clinical benefit 12.5 1.6
Pain intensity - Improved 10.9 1.6
Analgesic use - Improved 4.7 0.0
Karnofsky performance status - Improved 3.1 0.0
Body weight - Improved 3.1 0.0
Time Frame From the start of the study (first dose for that subject) until the end of the Adverse Event (AE) period (30 days after the last dose) or death, whichever was earlier (up to 8 months).
Adverse Event Reporting Description Safety evaluable population included all randomized subjects who received at least 1 dose of study drug.
 
Arm/Group Title Ruxolitinib (Safety Run-In) Ruxolitinib Placebo
Hide Arm/Group Description Subjects received capecitabine 2000 mg/m^2 daily (taken as 1000 mg/m2 twice daily [BID]) + ruxolitinib 15 mg BID Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]). Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
All-Cause Mortality
Ruxolitinib (Safety Run-In) Ruxolitinib Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ruxolitinib (Safety Run-In) Ruxolitinib Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/9 (55.56%)   32/59 (54.24%)   35/60 (58.33%) 
Blood and lymphatic system disorders       
Anemia  1  0/9 (0.00%)  4/59 (6.78%)  1/60 (1.67%) 
Febrile neutropenia  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Cardiac disorders       
Acute myocardial infarction  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Cardiorespiratory arrest  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Atrial fibrillation  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Myocardial infarction  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Eye disorders       
Diplopia  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  2/9 (22.22%)  2/59 (3.39%)  5/60 (8.33%) 
Diarrhoea  1  1/9 (11.11%)  2/59 (3.39%)  1/60 (1.67%) 
Large intestinal obstruction  1  0/9 (0.00%)  2/59 (3.39%)  0/60 (0.00%) 
Nausea  1  1/9 (11.11%)  2/59 (3.39%)  5/60 (8.33%) 
Ascites  1  0/9 (0.00%)  1/59 (1.69%)  2/60 (3.33%) 
Colitis  1  0/9 (0.00%)  1/59 (1.69%)  1/60 (1.67%) 
Colonic obstruction  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Constipation  1  0/9 (0.00%)  1/59 (1.69%)  1/60 (1.67%) 
Enteritis  1  0/9 (0.00%)  1/59 (1.69%)  1/60 (1.67%) 
Esophagitis  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Intestinal perforation  1  0/9 (0.00%)  1/59 (1.69%)  1/60 (1.67%) 
Obstruction gastric  1  0/9 (0.00%)  1/59 (1.69%)  3/60 (5.00%) 
Pancreatitis  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Rectal hemorrhage  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Vomiting  1  2/9 (22.22%)  1/59 (1.69%)  5/60 (8.33%) 
Abdominal distension  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Esophageal varices hemorrhage  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Fecaloma  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Hematemesis  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Necrotizing colitis  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Small intestinal obstruction  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Upper gastrointestinal hemorrhage  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Gastrointestinal Haemorrhage  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Intestinal Obstruction  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
General disorders       
Performance status decreased  1  0/9 (0.00%)  2/59 (3.39%)  1/60 (1.67%) 
Pyrexia  1  0/9 (0.00%)  2/59 (3.39%)  1/60 (1.67%) 
Asthenia  1  1/9 (11.11%)  0/59 (0.00%)  2/60 (3.33%) 
Device occlusion  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Fatigue  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
General physical health deterioration  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Pain  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Mucosal Inflammation  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Hepatobiliary disorders       
Bile duct obstruction  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Cholangitis  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Jaundice  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Infections and infestations       
Pneumonia  1  0/9 (0.00%)  5/59 (8.47%)  1/60 (1.67%) 
Cellulitis  1  0/9 (0.00%)  1/59 (1.69%)  1/60 (1.67%) 
Diverticulitis  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Empyema  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Klebsiella bacteremia  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Sepsis  1  1/9 (11.11%)  1/59 (1.69%)  0/60 (0.00%) 
Bacteremia  1  0/9 (0.00%)  0/59 (0.00%)  4/60 (6.67%) 
Pneumonia klebsiella  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Septic shock  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Urinary tract infection  1  1/9 (11.11%)  0/59 (0.00%)  1/60 (1.67%) 
Staphylococcal Sepsis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Streptococcal Sepsis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Injury, poisoning and procedural complications       
Hip fracture  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Investigations       
International normalized ratio increased  1  1/9 (11.11%)  0/59 (0.00%)  1/60 (1.67%) 
Prothrombin Time Prolonged  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/9 (0.00%)  3/59 (5.08%)  2/60 (3.33%) 
Hypoglycemia  1  0/9 (0.00%)  1/59 (1.69%)  1/60 (1.67%) 
Hyponatremia  1  0/9 (0.00%)  1/59 (1.69%)  1/60 (1.67%) 
Decreased appetite  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Diabetic ketoacidosis  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Failure to thrive  1  1/9 (11.11%)  0/59 (0.00%)  1/60 (1.67%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Muscular weakness  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Nervous system disorders       
Depressed level of consciousness  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Somnolence  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Syncope  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Transient ischemic attack  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Cerebrovascular accident  1  1/9 (11.11%)  0/59 (0.00%)  1/60 (1.67%) 
Convulsion  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Psychiatric disorders       
Confusional state  1  0/9 (0.00%)  1/59 (1.69%)  1/60 (1.67%) 
Mental status changes  1  1/9 (11.11%)  0/59 (0.00%)  1/60 (1.67%) 
Renal and urinary disorders       
Renal failure acute  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Renal failure  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Pleural effusion  1  0/9 (0.00%)  1/59 (1.69%)  0/60 (0.00%) 
Pulmonary embolism  1  1/9 (11.11%)  1/59 (1.69%)  2/60 (3.33%) 
Dyspnoea  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Surgical and medical procedures       
Colostomy  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Vascular disorders       
Hypotension  1  1/9 (11.11%)  1/59 (1.69%)  2/60 (3.33%) 
Peripheral arterial occlusive disease  1  0/9 (0.00%)  0/59 (0.00%)  1/60 (1.67%) 
Shock Haemorrhagic  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ruxolitinib (Safety Run-In) Ruxolitinib Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   57/59 (96.61%)   59/60 (98.33%) 
Blood and lymphatic system disorders       
Anemia  1  7/9 (77.78%)  30/59 (50.85%)  12/60 (20.00%) 
Thrombocytopenia  1  0/9 (0.00%)  5/59 (8.47%)  3/60 (5.00%) 
Leukopenia  1  3/9 (33.33%)  3/59 (5.08%)  2/60 (3.33%) 
Neutropenia  1  2/9 (22.22%)  3/59 (5.08%)  3/60 (5.00%) 
Leukocytosis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Eye disorders       
Dry eye  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  5/9 (55.56%)  22/59 (37.29%)  23/60 (38.33%) 
Diarrhea  1  4/9 (44.44%)  22/59 (37.29%)  17/60 (28.33%) 
Nausea  1  4/9 (44.44%)  21/59 (35.59%)  27/60 (45.00%) 
Stomatitis  1  3/9 (33.33%)  16/59 (27.12%)  8/60 (13.33%) 
Vomiting  1  5/9 (55.56%)  14/59 (23.73%)  21/60 (35.00%) 
Constipation  1  2/9 (22.22%)  11/59 (18.64%)  19/60 (31.67%) 
Flatulence  1  1/9 (11.11%)  7/59 (11.86%)  3/60 (5.00%) 
Abdominal pain upper  1  1/9 (11.11%)  6/59 (10.17%)  7/60 (11.67%) 
Ascites  1  1/9 (11.11%)  6/59 (10.17%)  10/60 (16.67%) 
Abdominal discomfort  1  0/9 (0.00%)  2/59 (3.39%)  3/60 (5.00%) 
Dyspepsia  1  0/9 (0.00%)  2/59 (3.39%)  6/60 (10.00%) 
Gastroesophageal reflux disease  1  1/9 (11.11%)  2/59 (3.39%)  5/60 (8.33%) 
Abdominal distension  1  0/9 (0.00%)  1/59 (1.69%)  3/60 (5.00%) 
Obstruction gastric  1  0/9 (0.00%)  1/59 (1.69%)  3/60 (5.00%) 
Dysphagia  1  2/9 (22.22%)  0/59 (0.00%)  0/60 (0.00%) 
Dry mouth  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Food poisoning  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Gastrointestinal haemorrhage  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Intestinal obstruction  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Tongue pigmentation  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
General disorders       
Fatigue  1  2/9 (22.22%)  29/59 (49.15%)  26/60 (43.33%) 
Pyrexia  1  1/9 (11.11%)  10/59 (16.95%)  5/60 (8.33%) 
Asthenia  1  2/9 (22.22%)  7/59 (11.86%)  8/60 (13.33%) 
Chills  1  1/9 (11.11%)  5/59 (8.47%)  2/60 (3.33%) 
Catheter site discharge  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Catheter site pain  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Chest pain  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Mucosal Inflammation  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Pain  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Suprapubic pain  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Temperature Intolerance  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Tenderness  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Hepatobiliary disorders       
Portal Vein Thrombosis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Infections and infestations       
Pneumonia  1  0/9 (0.00%)  6/59 (10.17%)  3/60 (5.00%) 
Candidiasis  1  1/9 (11.11%)  3/59 (5.08%)  4/60 (6.67%) 
Bacteremia  1  0/9 (0.00%)  0/59 (0.00%)  4/60 (6.67%) 
Bronchitis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Cellulitis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Nail Bed Infection  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Onychomycosis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Oral Candidiasis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Rhinitis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Sepsis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Staphylococcal Sepsis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Streptococcal Sepsis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Injury, poisoning and procedural complications       
Contusion  1  0/9 (0.00%)  4/59 (6.78%)  3/60 (5.00%) 
Open Wound  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Investigations       
Weight decreased  1  1/9 (11.11%)  5/59 (8.47%)  3/60 (5.00%) 
Aspartate aminotransferase increased  1  0/9 (0.00%)  4/59 (6.78%)  1/60 (1.67%) 
Blood alkaline phosphatase increased  1  2/9 (22.22%)  4/59 (6.78%)  3/60 (5.00%) 
International normalized ratio increased  1  1/9 (11.11%)  3/59 (5.08%)  4/60 (6.67%) 
Platelet count decreased  1  0/9 (0.00%)  0/59 (0.00%)  4/60 (6.67%) 
Prothrombin Time Prolonged  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  2/9 (22.22%)  12/59 (20.34%)  20/60 (33.33%) 
Dehydration  1  5/9 (55.56%)  12/59 (20.34%)  10/60 (16.67%) 
Edema peripheral  1  3/9 (33.33%)  7/59 (11.86%)  6/60 (10.00%) 
Hyponatremia  1  0/9 (0.00%)  6/59 (10.17%)  2/60 (3.33%) 
Edema  1  2/9 (22.22%)  4/59 (6.78%)  2/60 (3.33%) 
Hyperglycemia  1  0/9 (0.00%)  4/59 (6.78%)  5/60 (8.33%) 
Hypokalemia  1  0/9 (0.00%)  3/59 (5.08%)  2/60 (3.33%) 
Hypokalaemia  1  3/9 (33.33%)  0/59 (0.00%)  0/60 (0.00%) 
Failure to Thrive  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Hypoalbuminaemia  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Hypocalcaemia  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Hypomagnesaemia  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Hypophagia  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Hypophosphataemia  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Hypoproteinaemia  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Malnutrition  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/9 (11.11%)  8/59 (13.56%)  12/60 (20.00%) 
Musculoskeletal pain  1  0/9 (0.00%)  4/59 (6.78%)  1/60 (1.67%) 
Muscle spasms  1  1/9 (11.11%)  3/59 (5.08%)  1/60 (1.67%) 
Pain in extremity  1  0/9 (0.00%)  3/59 (5.08%)  3/60 (5.00%) 
Arthralgia  1  1/9 (11.11%)  2/59 (3.39%)  7/60 (11.67%) 
Nervous system disorders       
Dizziness  1  1/9 (11.11%)  7/59 (11.86%)  5/60 (8.33%) 
Peripheral sensory neuropathy  1  0/9 (0.00%)  6/59 (10.17%)  3/60 (5.00%) 
Neuropathy peripheral  1  0/9 (0.00%)  4/59 (6.78%)  3/60 (5.00%) 
Dysgeusia  1  0/9 (0.00%)  3/59 (5.08%)  1/60 (1.67%) 
Headache  1  0/9 (0.00%)  2/59 (3.39%)  4/60 (6.67%) 
Cerebrovascular Accident  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Convulsion  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Psychiatric disorders       
Confusional state  1  1/9 (11.11%)  5/59 (8.47%)  3/60 (5.00%) 
Depression  1  0/9 (0.00%)  3/59 (5.08%)  6/60 (10.00%) 
Insomnia  1  0/9 (0.00%)  3/59 (5.08%)  7/60 (11.67%) 
Somnolence  1  0/9 (0.00%)  3/59 (5.08%)  1/60 (1.67%) 
Mental Status Changes  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Renal and urinary disorders       
Urinary tract infection  1  2/9 (22.22%)  2/59 (3.39%)  7/60 (11.67%) 
Reproductive system and breast disorders       
Testicular Oedema  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  1/9 (11.11%)  7/59 (11.86%)  3/60 (5.00%) 
Dyspnea  1  0/9 (0.00%)  5/59 (8.47%)  11/60 (18.33%) 
Cough  1  1/9 (11.11%)  4/59 (6.78%)  4/60 (6.67%) 
Upper respiratory tract infection  1  1/9 (11.11%)  2/59 (3.39%)  3/60 (5.00%) 
Dyspnoea  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Oropharyngeal Pain  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Pleurisy  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Pleural Effusion  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Upper Respiratory Tract Irritation  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Skin and subcutaneous tissue disorders       
Palmar-plantar erythrodysesthesia syndrome  1  2/9 (22.22%)  19/59 (32.20%)  19/60 (31.67%) 
Dry skin  1  0/9 (0.00%)  3/59 (5.08%)  1/60 (1.67%) 
Rash  1  0/9 (0.00%)  1/59 (1.69%)  5/60 (8.33%) 
Skin hyperpigmentation  1  1/9 (11.11%)  1/59 (1.69%)  3/60 (5.00%) 
Rash maculopapular  1  0/9 (0.00%)  0/59 (0.00%)  3/60 (5.00%) 
Blister  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Onycholysis  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Rash Maculo-Papular  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Skin Discolouration  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Skin Exfoliation  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Vascular disorders       
Hypotension  1  1/9 (11.11%)  6/59 (10.17%)  2/60 (3.33%) 
Hemorrhoids  1  0/9 (0.00%)  3/59 (5.08%)  0/60 (0.00%) 
Orthostatic Hypotension  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Shock Haemorrhagic  1  1/9 (11.11%)  0/59 (0.00%)  0/60 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study; provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Incyte Corporation
Phone: 1-855-463-3463
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01423604     History of Changes
Other Study ID Numbers: 18424-262
First Submitted: August 22, 2011
First Posted: August 26, 2011
Results First Submitted: April 1, 2016
Results First Posted: August 29, 2016
Last Update Posted: February 12, 2018