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Trial record 75 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117479
Recruitment Status : Terminated (The study was terminated early based on the results of the planned interim analysis.)
First Posted : April 21, 2014
Results First Posted : July 11, 2017
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Ruxolitinib
Drug: Placebo
Drug: Capecitabine
Enrollment 321
Recruitment Details Participants with advanced or metastatic adenocarcinoma of the pancreas who had failed or were intolerant to first-line chemotherapy were randomized in the study.
Pre-assignment Details Treatment was started as soon as possible after randomization (within 3 days) and consisted of continuous 21-day cycles. Capecitabine was self-administered for the first 14 days of each cycle, and ruxolitinib/placebo was self-administered for the entire cycle.
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Hide Arm/Group Description Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Period Title: Overall Study
Started 161 160
Completed 5 [1] 4 [1]
Not Completed 156 156
Reason Not Completed
Death             13             8
Adverse Event             8             16
Subject decision             8             9
Disease progression             104             108
Noncompliance with study treatment             1             0
Study terminated by the sponsor             4             6
Physician Decision             7             2
Other unspecified             11             7
[1]
Treatment ongoing as of 20APR2016 for remaining participants in the study.
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine Total
Hide Arm/Group Description Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). Total of all reporting groups
Overall Number of Baseline Participants 161 160 321
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 161 participants 160 participants 321 participants
67.3  (9.35) 65.6  (9.55) 66.4  (9.48)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 161 participants 160 participants 321 participants
≤ 65 years 65 68 133
> 65 years 96 92 188
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 160 participants 321 participants
Female
66
  41.0%
64
  40.0%
130
  40.5%
Male
95
  59.0%
96
  60.0%
191
  59.5%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.
Time Frame Randomization until death due to any cause; up to the data cutoff 11FEB2016.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Overall Number of Participants Analyzed 161 160
Measure Type: Count of Participants
Unit of Measure: Participants
Observed
113
  70.2%
124
  77.5%
Censored
48
  29.8%
36
  22.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib Plus Capecitabine, Placebo Plus Capecitabine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.969
Confidence Interval (2-Sided) 95%
0.747 to 1.256
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
Time Frame Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Overall Number of Participants Analyzed 161 160
Median (95% Confidence Interval)
Unit of Measure: days
43.0
(41.0 to 46.0)
44.0
(42.0 to 48.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ruxolitinib Plus Capecitabine, Placebo Plus Capecitabine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.056
Confidence Interval (2-Sided) 95%
0.827 to 1.348
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants Achieving Progression Free Survival (PFS)
Hide Description PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.
Time Frame Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Overall Number of Participants Analyzed 161 160
Median (95% Confidence Interval)
Unit of Measure: percentage of participants
Survival rate at 3 months
18.9
(12.7 to 25.9)
19.8
(13.6 to 26.8)
Survival rate at 6 months
6.1
(2.5 to 12.2)
5.7
(2.3 to 11.3)
Survival rate at 9 months
2.5
(0.5 to 7.5)
3.4
(1.0 to 8.5)
Survival rate at 12 months
2.5
(0.5 to 7.5)
NA [1] 
(NA to NA)
[1]
PFS was not evaluable in the placebo group due to the insufficient number of participants with events.
4.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Time Frame Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Overall Number of Participants Analyzed 161 160
Measure Type: Number
Unit of Measure: percentage of participants
Objective response 3.7 1.9
Complete response 0 0
Partial response 3.7 1.9
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.
Time Frame Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all participants randomized to the study.
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Overall Number of Participants Analyzed 161 160
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median duration of response was not evaluable in the treatment group due to the insufficient number of participants with events.
6.Secondary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).
Time Frame Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Hide Arm/Group Description:
Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
Overall Number of Participants Analyzed 153 154
Measure Type: Count of Participants
Unit of Measure: Participants
Participants who had any TEAEs
152
  99.3%
152
  98.7%
Participants who had treatment-related TEAEs
73
  47.7%
59
  38.3%
Participants who had SAEs
94
  61.4%
83
  53.9%
Participants who had Grade 3 or higher TEAEs
112
  73.2%
113
  73.4%
Participants hospitalized because of a TEAE
89
  58.2%
75
  48.7%
Participants discontinued treatment due to TEAE
12
   7.8%
22
  14.3%
Participants with a dose modification due to TEAE
68
  44.4%
48
  31.2%
Participants on concomitant medication due to TEAE
131
  85.6%
122
  79.2%
Participants with procedure performed due to TEAE
60
  39.2%
46
  29.9%
Participants who had a fatal TEAE
20
  13.1%
15
   9.7%
Time Frame From the first dose of study medication through study termination up to 6-months or to the data cutoff 11Feb2016.
Adverse Event Reporting Description The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).
 
Arm/Group Title Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Hide Arm/Group Description Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID). Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
All-Cause Mortality
Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   94/153 (61.44%)   83/154 (53.90%) 
Blood and lymphatic system disorders     
Anaemia  1  4/153 (2.61%)  3/154 (1.95%) 
Disseminated intravascular coagulation  1  0/153 (0.00%)  1/154 (0.65%) 
Febrile neutropenia  1  0/153 (0.00%)  2/154 (1.30%) 
Leukocytosis  1  0/153 (0.00%)  1/154 (0.65%) 
Neutropenia  1  0/153 (0.00%)  2/154 (1.30%) 
Pancytopenia  1  0/153 (0.00%)  1/154 (0.65%) 
Cardiac disorders     
Acute myocardial infarction  1  1/153 (0.65%)  1/154 (0.65%) 
Cardiac arrest  1  2/153 (1.31%)  0/154 (0.00%) 
Cardiac failure  1  1/153 (0.65%)  0/154 (0.00%) 
Coronary artery disease  1  1/153 (0.65%)  0/154 (0.00%) 
Myocardial infarction  1  2/153 (1.31%)  1/154 (0.65%) 
Sinus tachycardia  1  0/153 (0.00%)  1/154 (0.65%) 
Tachycardia  1  0/153 (0.00%)  1/154 (0.65%) 
Eye disorders     
Conjunctival haemorrhage  1  1/153 (0.65%)  0/154 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  0/153 (0.00%)  1/154 (0.65%) 
Abdominal pain  1  6/153 (3.92%)  19/154 (12.34%) 
Abdominal pain upper  1  0/153 (0.00%)  1/154 (0.65%) 
Ascites  1  5/153 (3.27%)  1/154 (0.65%) 
Colitis  1  1/153 (0.65%)  0/154 (0.00%) 
Constipation  1  1/153 (0.65%)  4/154 (2.60%) 
Diarrhoea  1  5/153 (3.27%)  4/154 (2.60%) 
Duodenal obstruction  1  2/153 (1.31%)  3/154 (1.95%) 
Duodenal stenosis  1  0/153 (0.00%)  1/154 (0.65%) 
Dysphagia  1  1/153 (0.65%)  1/154 (0.65%) 
Enteritis  1  1/153 (0.65%)  0/154 (0.00%) 
Enterocolitis  1  1/153 (0.65%)  0/154 (0.00%) 
Gastrointestinal haemorrhage  1  2/153 (1.31%)  1/154 (0.65%) 
Haematemesis  1  1/153 (0.65%)  0/154 (0.00%) 
Ileus  1  1/153 (0.65%)  0/154 (0.00%) 
Impaired gastric emptying  1  1/153 (0.65%)  1/154 (0.65%) 
Intestinal infarction  1  0/153 (0.00%)  1/154 (0.65%) 
Intestinal obstruction  1  1/153 (0.65%)  2/154 (1.30%) 
Intestinal perforation  1  1/153 (0.65%)  0/154 (0.00%) 
Melaena  1  1/153 (0.65%)  1/154 (0.65%) 
Nausea  1  4/153 (2.61%)  5/154 (3.25%) 
Obstruction gastric  1  1/153 (0.65%)  0/154 (0.00%) 
Oesophageal varices haemorrhage  1  1/153 (0.65%)  0/154 (0.00%) 
Pancreatic pseudocyst  1  0/153 (0.00%)  1/154 (0.65%) 
Peritoneal haemorrhage  1  0/153 (0.00%)  1/154 (0.65%) 
Small intestinal obstruction  1  1/153 (0.65%)  2/154 (1.30%) 
Stomatitis  1  2/153 (1.31%)  0/154 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/153 (0.65%)  3/154 (1.95%) 
Vomiting  1  7/153 (4.58%)  4/154 (2.60%) 
General disorders     
Asthenia  1  0/153 (0.00%)  3/154 (1.95%) 
Device leakage  1  0/153 (0.00%)  1/154 (0.65%) 
Device malfunction  1  1/153 (0.65%)  0/154 (0.00%) 
Fatigue  1  0/153 (0.00%)  1/154 (0.65%) 
General physical health deterioration  1  0/153 (0.00%)  3/154 (1.95%) 
Hypothermia  1  1/153 (0.65%)  0/154 (0.00%) 
Malaise  1  0/153 (0.00%)  1/154 (0.65%) 
Multi-organ failure  1  1/153 (0.65%)  0/154 (0.00%) 
Oedema  1  0/153 (0.00%)  1/154 (0.65%) 
Pain  1  3/153 (1.96%)  2/154 (1.30%) 
Pyrexia  1  8/153 (5.23%)  1/154 (0.65%) 
Systemic inflammatory response syndrome  1  0/153 (0.00%)  1/154 (0.65%) 
Hepatobiliary disorders     
Bile duct obstruction  1  1/153 (0.65%)  3/154 (1.95%) 
Bile duct stenosis  1  1/153 (0.65%)  0/154 (0.00%) 
Biliary dilatation  1  0/153 (0.00%)  1/154 (0.65%) 
Biloma  1  0/153 (0.00%)  1/154 (0.65%) 
Cholangitis  1  3/153 (1.96%)  2/154 (1.30%) 
Cholecystitis acute  1  1/153 (0.65%)  0/154 (0.00%) 
Cholelithiasis  1  0/153 (0.00%)  1/154 (0.65%) 
Hepatic failure  1  1/153 (0.65%)  0/154 (0.00%) 
Hepatic function abnormal  1  1/153 (0.65%)  0/154 (0.00%) 
Hyperbilirubinaemia  1  0/153 (0.00%)  2/154 (1.30%) 
Jaundice  1  3/153 (1.96%)  3/154 (1.95%) 
Jaundice cholestatic  1  0/153 (0.00%)  1/154 (0.65%) 
Portal vein thrombosis  1  0/153 (0.00%)  1/154 (0.65%) 
Infections and infestations     
Bacteraemia  1  0/153 (0.00%)  2/154 (1.30%) 
Biliary sepsis  1  0/153 (0.00%)  2/154 (1.30%) 
Biliary tract infection  1  2/153 (1.31%)  1/154 (0.65%) 
Bronchitis  1  1/153 (0.65%)  0/154 (0.00%) 
Candida infection  1  1/153 (0.65%)  0/154 (0.00%) 
Cholangitis suppurative  1  1/153 (0.65%)  0/154 (0.00%) 
Device related infection  1  1/153 (0.65%)  0/154 (0.00%) 
Escherichia infection  1  1/153 (0.65%)  0/154 (0.00%) 
Infection  1  2/153 (1.31%)  1/154 (0.65%) 
Klebsiella infection  1  2/153 (1.31%)  0/154 (0.00%) 
Klebsiella sepsis  1  1/153 (0.65%)  0/154 (0.00%) 
Liver abscess  1  0/153 (0.00%)  1/154 (0.65%) 
Lower respiratory tract infection  1  1/153 (0.65%)  0/154 (0.00%) 
Peritonitis  1  1/153 (0.65%)  0/154 (0.00%) 
Peritonitis bacterial  1  1/153 (0.65%)  0/154 (0.00%) 
Pneumonia  1  4/153 (2.61%)  7/154 (4.55%) 
Pneumonia klebsiella  1  0/153 (0.00%)  1/154 (0.65%) 
Postoperative abscess  1  0/153 (0.00%)  1/154 (0.65%) 
Sepsis  1  5/153 (3.27%)  5/154 (3.25%) 
Septic shock  1  0/153 (0.00%)  2/154 (1.30%) 
Skin candida  1  1/153 (0.65%)  0/154 (0.00%) 
Urinary tract infection  1  2/153 (1.31%)  0/154 (0.00%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/153 (0.65%)  0/154 (0.00%) 
Fall  1  1/153 (0.65%)  0/154 (0.00%) 
Spinal compression fracture  1  1/153 (0.65%)  0/154 (0.00%) 
Investigations     
Blood bilirubin increased  1  4/153 (2.61%)  1/154 (0.65%) 
Hepatic enzyme increased  1  0/153 (0.00%)  1/154 (0.65%) 
Liver function test abnormal  1  1/153 (0.65%)  0/154 (0.00%) 
Platelet count decreased  1  1/153 (0.65%)  0/154 (0.00%) 
Transaminases increased  1  1/153 (0.65%)  0/154 (0.00%) 
White blood cell count decreased  1  1/153 (0.65%)  0/154 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/153 (0.65%)  1/154 (0.65%) 
Dehydration  1  7/153 (4.58%)  4/154 (2.60%) 
Failure to thrive  1  1/153 (0.65%)  2/154 (1.30%) 
Hyperglycaemia  1  3/153 (1.96%)  2/154 (1.30%) 
Hyperkalaemia  1  2/153 (1.31%)  0/154 (0.00%) 
Hypoglycaemia  1  3/153 (1.96%)  1/154 (0.65%) 
Hypokalaemia  1  2/153 (1.31%)  2/154 (1.30%) 
Hyponatraemia  1  5/153 (3.27%)  1/154 (0.65%) 
Hypovolaemia  1  0/153 (0.00%)  1/154 (0.65%) 
Malnutrition  1  1/153 (0.65%)  1/154 (0.65%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/153 (0.65%)  3/154 (1.95%) 
Flank pain  1  0/153 (0.00%)  2/154 (1.30%) 
Mobility decreased  1  0/153 (0.00%)  1/154 (0.65%) 
Muscular weakness  1  1/153 (0.65%)  3/154 (1.95%) 
Musculoskeletal pain  1  0/153 (0.00%)  1/154 (0.65%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  2/153 (1.31%)  0/154 (0.00%) 
Metastases to peritoneum  1  1/153 (0.65%)  0/154 (0.00%) 
Small intestine carcinoma metastatic  1  1/153 (0.65%)  0/154 (0.00%) 
Tumour associated fever  1  2/153 (1.31%)  0/154 (0.00%) 
Tumour pain  1  1/153 (0.65%)  0/154 (0.00%) 
Nervous system disorders     
Complex regional pain syndrome  1  1/153 (0.65%)  0/154 (0.00%) 
Dizziness  1  0/153 (0.00%)  1/154 (0.65%) 
Encephalopathy  1  0/153 (0.00%)  1/154 (0.65%) 
Headache  1  1/153 (0.65%)  0/154 (0.00%) 
Ischaemic stroke  1  1/153 (0.65%)  0/154 (0.00%) 
Lethargy  1  0/153 (0.00%)  1/154 (0.65%) 
Parkinson's disease  1  1/153 (0.65%)  0/154 (0.00%) 
Syncope  1  1/153 (0.65%)  1/154 (0.65%) 
Unresponsive to stimuli  1  0/153 (0.00%)  1/154 (0.65%) 
Psychiatric disorders     
Confusional state  1  0/153 (0.00%)  1/154 (0.65%) 
Delirium  1  2/153 (1.31%)  0/154 (0.00%) 
Mental status changes  1  1/153 (0.65%)  0/154 (0.00%) 
Anxiety  1  0/153 (0.00%)  1/154 (0.65%) 
Renal and urinary disorders     
Renal failure  1  3/153 (1.96%)  0/154 (0.00%) 
Renal failure acute  1  5/153 (3.27%)  1/154 (0.65%) 
Ureteric obstruction  1  1/153 (0.65%)  0/154 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  0/153 (0.00%)  1/154 (0.65%) 
Chronic obstructive pulmonary disease  1  1/153 (0.65%)  0/154 (0.00%) 
Cough  1  0/153 (0.00%)  1/154 (0.65%) 
Dyspnoea  1  5/153 (3.27%)  4/154 (2.60%) 
Epistaxis  1  1/153 (0.65%)  0/154 (0.00%) 
Hypoxia  1  0/153 (0.00%)  1/154 (0.65%) 
Pleural effusion  1  1/153 (0.65%)  5/154 (3.25%) 
Pulmonary embolism  1  5/153 (3.27%)  2/154 (1.30%) 
Pulmonary oedema  1  0/153 (0.00%)  1/154 (0.65%) 
Respiratory arrest  1  1/153 (0.65%)  0/154 (0.00%) 
Respiratory failure  1  1/153 (0.65%)  0/154 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/153 (0.00%)  1/154 (0.65%) 
Vascular disorders     
Embolism  1  1/153 (0.65%)  2/154 (1.30%) 
Haematoma  1  1/153 (0.65%)  0/154 (0.00%) 
Hypertension  1  0/153 (0.00%)  1/154 (0.65%) 
Hypotension  1  3/153 (1.96%)  2/154 (1.30%) 
Phlebitis  1  0/153 (0.00%)  1/154 (0.65%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ruxolitinib Plus Capecitabine Placebo Plus Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   147/153 (96.08%)   145/154 (94.16%) 
Blood and lymphatic system disorders     
Anemia  1  45/153 (29.41%)  22/154 (14.29%) 
Gastrointestinal disorders     
Nausea  1  45/153 (29.41%)  49/154 (31.82%) 
Diarrhea  1  42/153 (27.45%)  36/154 (23.38%) 
Abdominal pain  1  36/153 (23.53%)  49/154 (31.82%) 
Vomiting  1  30/153 (19.61%)  46/154 (29.87%) 
Constipation  1  33/153 (21.57%)  27/154 (17.53%) 
Stomatitis  1  30/153 (19.61%)  18/154 (11.69%) 
Ascites  1  21/153 (13.73%)  20/154 (12.99%) 
Abdominal distension  1  15/153 (9.80%)  11/154 (7.14%) 
Abdominal pain upper  1  13/153 (8.50%)  14/154 (9.09%) 
Flatulence  1  9/153 (5.88%)  3/154 (1.95%) 
Dry mouth  1  3/153 (1.96%)  8/154 (5.19%) 
General disorders     
Fatigue  1  47/153 (30.72%)  50/154 (32.47%) 
Pyrexia  1  25/153 (16.34%)  13/154 (8.44%) 
Oedema peripheral  1  18/153 (11.76%)  35/154 (22.73%) 
Asthenia  1  17/153 (11.11%)  18/154 (11.69%) 
Oedema  1  11/153 (7.19%)  3/154 (1.95%) 
Chills  1  8/153 (5.23%)  4/154 (2.60%) 
Infections and infestations     
Urinary tract infection  1  9/153 (5.88%)  6/154 (3.90%) 
Injury, poisoning and procedural complications     
Fall  1  10/153 (6.54%)  4/154 (2.60%) 
Investigations     
Aspartate aminotransferase increased  1  10/153 (6.54%)  3/154 (1.95%) 
Weight decreased  1  10/153 (6.54%)  6/154 (3.90%) 
Alanine aminotransferase increased  1  9/153 (5.88%)  4/154 (2.60%) 
Metabolism and nutrition disorders     
Decreased appetite  1  30/153 (19.61%)  47/154 (30.52%) 
Dehydration  1  10/153 (6.54%)  9/154 (5.84%) 
Hyponatraemia  1  9/153 (5.88%)  5/154 (3.25%) 
Hyperglycaemia  1  4/153 (2.61%)  9/154 (5.84%) 
Hypokalaemia  1  17/153 (11.11%)  12/154 (7.79%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  19/153 (12.42%)  16/154 (10.39%) 
Arthralgia  1  8/153 (5.23%)  4/154 (2.60%) 
Muscular weakness  1  7/153 (4.58%)  5/154 (3.25%) 
Pain in extremity  1  8/153 (5.23%)  2/154 (1.30%) 
Nervous system disorders     
Dizziness  1  19/153 (12.42%)  12/154 (7.79%) 
Dysgeusia  1  4/153 (2.61%)  8/154 (5.19%) 
Psychiatric disorders     
Insomnia  1  13/153 (8.50%)  7/154 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  9/153 (5.88%)  19/154 (12.34%) 
Cough  1  10/153 (6.54%)  13/154 (8.44%) 
Hiccups  1  9/153 (5.88%)  2/154 (1.30%) 
Pleural effusion  1  8/153 (5.23%)  2/154 (1.30%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome  1  37/153 (24.18%)  26/154 (16.88%) 
Vascular disorders     
Hypotension  1  12/153 (7.84%)  8/154 (5.19%) 
Hypertension  1  8/153 (5.23%)  3/154 (1.95%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation at the recommendation of the Data Monitoring Committee.
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: 855 463-3463
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02117479     History of Changes
Other Study ID Numbers: INCB 18424-362
First Submitted: April 16, 2014
First Posted: April 21, 2014
Results First Submitted: February 9, 2017
Results First Posted: July 11, 2017
Last Update Posted: March 26, 2019