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Trial record 31 of 196 for:    colon cancer | ( Map: Colorado, United States )

Study of Ruxolitinib in Colorectal Cancer Patients

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: NCT02119676
Recruitment Status : Terminated (Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision.)
First Posted : April 22, 2014
Results First Posted : June 14, 2017
Last Update Posted : February 13, 2018
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 CRC (Colorectal Cancer)
Interventions Drug: Ruxolitinib
Drug: Regorafenib
Drug: Placebo
Enrollment 396
Recruitment Details In Substudy 1, the first subject was enrolled on 29 OCT 2014, and the last subject was enrolled on 23 JUL 2015. In Substudy 2, the first subject was enrolled on 05 NOV 2014, and the last subject was enrolled on 02 OCT 2015.
Pre-assignment Details Substudy 1; 4 participants were assigned a randomization number but were not given study drug because of clinical deterioration or withdrawal of consent. Substudy 2; 9 participants were assigned a randomization number, but weren't given study drug due to clinical deterioration, withdrawal of consent or not meeting all of the eligibility criteria.
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Hide Arm/Group Description Ruxolitinib 15 mg twice a day (BID) continuous with regorafenib 160 mg once daily (QD) for the first 21 days of each 28-day cycle. Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Period Title: Overall Study
Started 87 88 110 111
Treated Patients 85 86 106 106
Completed [1] 4 2 13 10
Not Completed 83 86 97 101
Reason Not Completed
Adverse Event             9             17             10             10
Disease progression             53             55             68             73
Patient decision, inc. consent withdrawn             4             5             5             6
Physician Decision             4             2             3             2
Death             9             3             2             1
Noncompliance             0             1             0             0
Lost to Follow-up             0             0             1             0
Protocol deviation             0             0             1             0
Other, unspecified             2             1             3             4
Did not receive study med             2             2             4             5
[1]
Ongoing treatment at time of termination. Termination=Substudy 1: 27Jan2016; Substudy 2: 11Feb2016.
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib Total
Hide Arm/Group Description Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 87 88 110 111 396
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population consisted of participants that were randomized in the study.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 87 participants 88 participants 110 participants 111 participants 396 participants
60.8
(34.0 to 84.0)
59.5
(36.0 to 81.0)
59.0
(37.0 to 79.0)
59.2
(19.0 to 83.0)
59.6
(19 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 110 participants 111 participants 396 participants
Female
34
  39.1%
32
  36.4%
48
  43.6%
54
  48.6%
168
  42.4%
Male
53
  60.9%
56
  63.6%
62
  56.4%
57
  51.4%
228
  57.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 110 participants 111 participants 396 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   2.3%
10
   9.1%
9
   8.1%
21
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.3%
Black or African American
7
   8.0%
7
   8.0%
6
   5.5%
7
   6.3%
27
   6.8%
White
70
  80.5%
70
  79.5%
84
  76.4%
80
  72.1%
304
  76.8%
More than one race
10
  11.5%
9
  10.2%
5
   4.5%
11
   9.9%
35
   8.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
4
   3.6%
4
   3.6%
8
   2.0%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.
Time Frame Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Hide Arm/Group Description:
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Overall Number of Participants Analyzed 87 88 110 111
Median (95% Confidence Interval)
Unit of Measure: months
4.6
(3.5 to 5.4)
5.3
(4.3 to 6.0)
11.4
(9.0 to 13.2)
10.9 [1] 
(7.2 to NA)
[1]
Not estimable due to insufficient number of participants with events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Substudy 1: Ruxolitinib + Regorafenib, Substudy 1: Placebo + Regorafenib
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments 1-sided
Method Log Rank
Comments Log-rank test stratified by modified Glasgow Prognostic Score (mGPS) and geographical region.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.73 to 1.49
Estimation Comments Estimated using a Cox regression model with Efron’s method used for ties, stratified by mGPS score and geographical region
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Substudy 2: Ruxolitinib + Regorafenib, Substudy 2: Placebo + Regorafenib
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments 1-sided
Method Log Rank
Comments Log rank test stratified by geographical region.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.48 to 1.23
Estimation Comments Estimated using Cox regression model with Efron’s method used for ties, stratified by geographical region
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 Longest Diameter (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 Baseline through disease progression, or death due to any cause if sooner; up to 16 months or data cut-off 11 FEB 2016.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Hide Arm/Group Description:
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Overall Number of Participants Analyzed 87 88 110 111
Median (95% Confidence Interval)
Unit of Measure: months
2.2
(1.9 to 3.0)
2.1
(1.8 to 2.7)
3.5
(3.0 to 3.8)
2.0
(1.9 to 3.1)
3.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions without new lesion; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions, non-target lesion not progressed, and no new lesion; Progressive Disease=20% increase in sum of longest diameter of target lesions, or non-target lesion progression, or identification of new lesion; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants randomized.
Time Frame Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Hide Arm/Group Description:
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Overall Number of Participants Analyzed 87 88 110 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
0.0
(0.0 to 4.2)
0.0
(0.0 to 4.1)
2.7
(0.6 to 7.8)
4.5
(1.5 to 10.2)
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined as the time from response (CR/PR) 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.
Time Frame Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because outcome measure has not been analyzed. Duration of response analyses was not done since there were no responders in Substudy 1 and very few responders in Substudy 2 at data cutoff (27JAN2016 for Substudy 1 and 11Feb2016 for Substudy 2). Duration of response analysis was not done in both substudies.
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Hide Arm/Group Description:
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants Achieving Disease Control
Hide Description Disease control as measured by the percentage of participants whose best response was complete response (CR), partial response (PR), or stable disease (SD) per RECIST v.1.1.
Time Frame Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Hide Arm/Group Description:
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Overall Number of Participants Analyzed 87 88 110 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.2
(29.9 to 51.3)
34.1
(24.3 to 45.0)
61.8
(52.1 to 70.9)
36.9
(28.0 to 46.6)
6.Secondary Outcome
Title Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Hide Description TEAEs were defined as any adverse event (AE) during the study that began or worsened on or after the date of first dose of investigational product.
Time Frame Baseline through approximately 30 days post treatment discontinuation;up to 16 months or data cut-off 27JAN 2016 for Substudy 1 and up to the data cut-off of 11FEB2016 for Substudy 2.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population consists of all enrolled participants that received at least one dose of study drug.
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Hide Arm/Group Description:
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
Overall Number of Participants Analyzed 85 86 106 106
Measure Type: Number
Unit of Measure: percentage of participants
Participants with any TEAEs 100.0 100.0 100.0 99.1
Participants with Grade 3/4 TEAEs 82.4 81.4 77.4 72.6
Participants with any serious TEAE 57.6 48.8 34.9 34.9
Participants with a fatal TEAE 15.3 9.3 1.9 3.8
Participants who discontinued drug due to of TEAEs 14.1 19.8 11.3 10.4
Time Frame From the first dose of study medication up to 16 months or data cut-off 11 FEB 2016.
Adverse Event Reporting Description The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.
 
Arm/Group Title Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Hide Arm/Group Description Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle. Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
All-Cause Mortality
Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/85 (57.65%)   42/86 (48.84%)   37/106 (34.91%)   37/106 (34.91%) 
Blood and lymphatic system disorders         
Anaemia  1  0/85 (0.00%)  0/86 (0.00%)  4/106 (3.77%)  0/106 (0.00%) 
Cardiac disorders         
Arrhythmia  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Atrial fibrillation  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Atrial tachycardia  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Cardiac failure congestive  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Myocardial infarction  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Tachycardia  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Endocrine disorders         
Hyperthyroidism  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  6/85 (7.06%)  7/86 (8.14%)  4/106 (3.77%)  5/106 (4.72%) 
Abdominal pain upper  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Anal fistula  1  1/85 (1.18%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Ascites  1  2/85 (2.35%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Bloody peritoneal effluent  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Constipation  1  0/85 (0.00%)  1/86 (1.16%)  1/106 (0.94%)  0/106 (0.00%) 
Diarrhoea  1  1/85 (1.18%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Dieulafoy's vascular malformation  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Gastrointestinal haemorrhage  1  1/85 (1.18%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Gastrointestinal inflammation  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Haematemesis  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Intestinal obstruction  1  1/85 (1.18%)  2/86 (2.33%)  1/106 (0.94%)  2/106 (1.89%) 
Intestinal perforation  1  2/85 (2.35%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Large intestinal obstruction  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Nausea  1  3/85 (3.53%)  2/86 (2.33%)  1/106 (0.94%)  3/106 (2.83%) 
Rectal haemorrhage  1  1/85 (1.18%)  0/86 (0.00%)  2/106 (1.89%)  0/106 (0.00%) 
Small intestinal obstruction  1  2/85 (2.35%)  1/86 (1.16%)  0/106 (0.00%)  5/106 (4.72%) 
Stomatitis  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Subileus  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Vomiting  1  2/85 (2.35%)  4/86 (4.65%)  3/106 (2.83%)  4/106 (3.77%) 
Abdominal distension  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Anal haemorrhage  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Ileus  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Pancreatitis  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  1/106 (0.94%) 
Proctalgia  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
General disorders         
Asthenia  1  2/85 (2.35%)  1/86 (1.16%)  1/106 (0.94%)  0/106 (0.00%) 
Disease progression  1  2/85 (2.35%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
General physical health deterioration  1  4/85 (4.71%)  3/86 (3.49%)  1/106 (0.94%)  1/106 (0.94%) 
Malaise  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Multi-organ failure  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Obstruction  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Oedema peripheral  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Pain  1  0/85 (0.00%)  3/86 (3.49%)  1/106 (0.94%)  1/106 (0.94%) 
Pyrexia  1  3/85 (3.53%)  2/86 (2.33%)  1/106 (0.94%)  3/106 (2.83%) 
Systemic inflammatory response syndrome  1  1/85 (1.18%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Hepatobiliary disorders  1  5/85 (5.88%)  2/86 (2.33%)  0/106 (0.00%)  0/106 (0.00%) 
Fatigue  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Hepatobiliary disorders         
Bile duct obstruction  1  0/85 (0.00%)  1/86 (1.16%)  1/106 (0.94%)  0/106 (0.00%) 
Cholangitis acute  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Hepatic failure  1  2/85 (2.35%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Hepatorenal syndrome  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Hyperbilirubinaemia  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Jaundice cholestatic  1  2/85 (2.35%)  1/86 (1.16%)  0/106 (0.00%)  1/106 (0.94%) 
Jaundice  1  0/85 (0.00%)  0/86 (0.00%)  2/106 (1.89%)  0/106 (0.00%) 
Infections and infestations         
Arthritis infective  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Atypical pneumonia  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Biliary sepsis  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Gastroenteritis viral  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Hepatic infection bacterial  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Infection  1  2/85 (2.35%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Liver abscess  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Perirectal abscess  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Peritonitis  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Peritonitis bacterial  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Pneumonia  1  5/85 (5.88%)  2/86 (2.33%)  0/106 (0.00%)  0/106 (0.00%) 
Sepsis  1  6/85 (7.06%)  1/86 (1.16%)  1/106 (0.94%)  1/106 (0.94%) 
Urinary tract infection  1  2/85 (2.35%)  1/86 (1.16%)  2/106 (1.89%)  0/106 (0.00%) 
Urosepsis  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Biliary tract infection  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Device related infection  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Diverticulitis  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Endocarditis  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Upper respiratory tract infection  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Injury, poisoning and procedural complications         
Fall  1  1/85 (1.18%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Femur fracture  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Incisional hernia, obstructive  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Seroma  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Aspartate aminotransferase increased  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Blood alkaline phosphatase increased  1  1/85 (1.18%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Blood bilirubin increased  1  4/85 (4.71%)  1/86 (1.16%)  0/106 (0.00%)  3/106 (2.83%) 
Blood creatinine increased  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Haemoglobin decreased  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Hepatic enzyme abnormal  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Lipase increased  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Platelet count decreased  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Metabolism and nutrition disorders         
Dehydration  1  1/85 (1.18%)  0/86 (0.00%)  1/106 (0.94%)  2/106 (1.89%) 
Hyperkalaemia  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Hypocalcaemia  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Malnutrition  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Decreased appetite  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  2/106 (1.89%) 
Hypokalaemia  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  1/106 (0.94%) 
Hyponatraemia  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/85 (0.00%)  1/86 (1.16%)  1/106 (0.94%)  0/106 (0.00%) 
Back pain  1  3/85 (3.53%)  1/86 (1.16%)  3/106 (2.83%)  0/106 (0.00%) 
Musculoskeletal pain  1  1/85 (1.18%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Systemic lupus erythematosus  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Pathological fracture  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung neoplasm  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Malignant neoplasm progression  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Neoplasm progression  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Tumour associated fever  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Nervous system disorders         
Cerebrospinal fistula  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Cerebrovascular accident  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Encephalopathy  1  1/85 (1.18%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Haemorrhage intracranial  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Headache  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Hepatic encephalopathy  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Lacunar infarction  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Syncope  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Grand mal convulsion  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Hypoaesthesia  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Speech disorder  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Spinal cord compression  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Transient ischaemic attack  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
VIIth nerve paralysis  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Psychiatric disorders         
Completed suicide  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Renal and urinary disorders         
Haematuria  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Renal failure acute  1  2/85 (2.35%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Vesical fistula  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Hydronephrosis  1  0/85 (0.00%)  0/86 (0.00%)  2/106 (1.89%)  0/106 (0.00%) 
Renal injury  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Renal vein thrombosis  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Ureteric obstruction  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  1/85 (1.18%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Chronic obstructive pulmonary disease  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Dyspnoea  1  0/85 (0.00%)  2/86 (2.33%)  5/106 (4.72%)  1/106 (0.94%) 
Haemoptysis  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Hypoxia  1  1/85 (1.18%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Pleural effusion  1  1/85 (1.18%)  1/86 (1.16%)  2/106 (1.89%)  1/106 (0.94%) 
Pneumonia aspiration  1  1/85 (1.18%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Respiratory failure  1  0/85 (0.00%)  1/86 (1.16%)  1/106 (0.94%)  0/106 (0.00%) 
Lower respiratory tract inflammation  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Pneumonitis  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Pneumothorax  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  1/106 (0.94%) 
Skin and subcutaneous tissue disorders         
Palmar-plantar erythrodysaesthesia syndrome  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
Rash  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Rash maculo-papular  1  0/85 (0.00%)  0/86 (0.00%)  0/106 (0.00%)  1/106 (0.94%) 
Vascular disorders         
Embolism venous  1  0/85 (0.00%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Hypertension  1  0/85 (0.00%)  2/86 (2.33%)  2/106 (1.89%)  0/106 (0.00%) 
Hypotension  1  1/85 (1.18%)  1/86 (1.16%)  0/106 (0.00%)  0/106 (0.00%) 
Orthostatic hypotension  1  1/85 (1.18%)  0/86 (0.00%)  0/106 (0.00%)  0/106 (0.00%) 
Embolism  1  0/85 (0.00%)  0/86 (0.00%)  1/106 (0.94%)  0/106 (0.00%) 
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%
Substudy 1: Ruxolitinib + Regorafenib Substudy 1: Placebo + Regorafenib Substudy 2: Ruxolitinib + Regorafenib Substudy 2: Placebo + Regorafenib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   85/85 (100.00%)   86/86 (100.00%)   106/106 (100.00%)   105/106 (99.06%) 
Blood and lymphatic system disorders         
Anaemia  1  10/85 (11.76%)  12/86 (13.95%)  27/106 (25.47%)  12/106 (11.32%) 
Thrombocytopenia  1  3/85 (3.53%)  1/86 (1.16%)  4/106 (3.77%)  6/106 (5.66%) 
Endocrine disorders         
Hypothyroidism  1  2/85 (2.35%)  6/86 (6.98%)  4/106 (3.77%)  3/106 (2.83%) 
Gastrointestinal disorders         
Abdominal pain  1  21/85 (24.71%)  24/86 (27.91%)  24/106 (22.64%)  26/106 (24.53%) 
Abdominal pain upper  1  4/85 (4.71%)  6/86 (6.98%)  6/106 (5.66%)  11/106 (10.38%) 
Ascites  1  6/85 (7.06%)  2/86 (2.33%)  2/106 (1.89%)  7/106 (6.60%) 
Constipation  1  27/85 (31.76%)  21/86 (24.42%)  24/106 (22.64%)  22/106 (20.75%) 
Diarrhoea  1  32/85 (37.65%)  27/86 (31.40%)  41/106 (38.68%)  29/106 (27.36%) 
Dry mouth  1  3/85 (3.53%)  6/86 (6.98%)  4/106 (3.77%)  4/106 (3.77%) 
Flatulence  1  5/85 (5.88%)  6/86 (6.98%)  5/106 (4.72%)  5/106 (4.72%) 
Nausea  1  22/85 (25.88%)  22/86 (25.58%)  30/106 (28.30%)  22/106 (20.75%) 
Stomatitis  1  21/85 (24.71%)  18/86 (20.93%)  19/106 (17.92%)  21/106 (19.81%) 
Vomiting  1  16/85 (18.82%)  20/86 (23.26%)  24/106 (22.64%)  15/106 (14.15%) 
Abdominal distension  1  2/85 (2.35%)  4/86 (4.65%)  1/106 (0.94%)  7/106 (6.60%) 
General disorders         
Asthenia  1  22/85 (25.88%)  22/86 (25.58%)  19/106 (17.92%)  23/106 (21.70%) 
Chills  1  2/85 (2.35%)  5/86 (5.81%)  5/106 (4.72%)  4/106 (3.77%) 
Fatigue  1  29/85 (34.12%)  31/86 (36.05%)  43/106 (40.57%)  47/106 (44.34%) 
Oedema peripheral  1  8/85 (9.41%)  9/86 (10.47%)  2/106 (1.89%)  8/106 (7.55%) 
Pain  1  5/85 (5.88%)  4/86 (4.65%)  3/106 (2.83%)  6/106 (5.66%) 
Pyrexia  1  16/85 (18.82%)  15/86 (17.44%)  20/106 (18.87%)  16/106 (15.09%) 
Chest pain  1  3/85 (3.53%)  3/86 (3.49%)  7/106 (6.60%)  4/106 (3.77%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  5/85 (5.88%)  3/86 (3.49%)  4/106 (3.77%)  5/106 (4.72%) 
Infections and infestations         
Urinary tract infection  1  11/85 (12.94%)  6/86 (6.98%)  8/106 (7.55%)  8/106 (7.55%) 
Investigations         
Alanine aminotransferase increased  1  5/85 (5.88%)  8/86 (9.30%)  8/106 (7.55%)  11/106 (10.38%) 
Aspartate aminotransferase increased  1  8/85 (9.41%)  14/86 (16.28%)  12/106 (11.32%)  13/106 (12.26%) 
Blood alkaline phosphatase increased  1  4/85 (4.71%)  6/86 (6.98%)  4/106 (3.77%)  5/106 (4.72%) 
Blood bilirubin increased  1  12/85 (14.12%)  12/86 (13.95%)  7/106 (6.60%)  15/106 (14.15%) 
Lipase increased  1  1/85 (1.18%)  5/86 (5.81%)  5/106 (4.72%)  5/106 (4.72%) 
Weight decreased  1  13/85 (15.29%)  15/86 (17.44%)  13/106 (12.26%)  16/106 (15.09%) 
Metabolism and nutrition disorders         
Decreased appetite  1  31/85 (36.47%)  31/86 (36.05%)  28/106 (26.42%)  35/106 (33.02%) 
Dehydration  1  11/85 (12.94%)  7/86 (8.14%)  8/106 (7.55%)  12/106 (11.32%) 
Hypoalbuminaemia  1  3/85 (3.53%)  6/86 (6.98%)  1/106 (0.94%)  1/106 (0.94%) 
Hypokalaemia  1  8/85 (9.41%)  6/86 (6.98%)  6/106 (5.66%)  6/106 (5.66%) 
Hypophosphataemia  1  11/85 (12.94%)  5/86 (5.81%)  8/106 (7.55%)  13/106 (12.26%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  7/85 (8.24%)  5/86 (5.81%)  8/106 (7.55%)  8/106 (7.55%) 
Back pain  1  15/85 (17.65%)  11/86 (12.79%)  14/106 (13.21%)  11/106 (10.38%) 
Muscle spasms  1  7/85 (8.24%)  2/86 (2.33%)  9/106 (8.49%)  11/106 (10.38%) 
Muscular weakness  1  5/85 (5.88%)  0/86 (0.00%)  3/106 (2.83%)  1/106 (0.94%) 
Myalgia  1  6/85 (7.06%)  5/86 (5.81%)  7/106 (6.60%)  13/106 (12.26%) 
Pain in extremity  1  5/85 (5.88%)  2/86 (2.33%)  10/106 (9.43%)  10/106 (9.43%) 
Musculoskeletal pain  1  4/85 (4.71%)  3/86 (3.49%)  6/106 (5.66%)  5/106 (4.72%) 
Nervous system disorders         
Dizziness  1  4/85 (4.71%)  5/86 (5.81%)  11/106 (10.38%)  5/106 (4.72%) 
Dysgeusia  1  6/85 (7.06%)  6/86 (6.98%)  6/106 (5.66%)  4/106 (3.77%) 
Headache  1  13/85 (15.29%)  16/86 (18.60%)  21/106 (19.81%)  26/106 (24.53%) 
Neuropathy peripheral  1  2/85 (2.35%)  2/86 (2.33%)  9/106 (8.49%)  6/106 (5.66%) 
Psychiatric disorders         
Insomnia  1  7/85 (8.24%)  5/86 (5.81%)  11/106 (10.38%)  5/106 (4.72%) 
Renal and urinary disorders         
Pollakiuria  1  6/85 (7.06%)  1/86 (1.16%)  2/106 (1.89%)  2/106 (1.89%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  9/85 (10.59%)  8/86 (9.30%)  10/106 (9.43%)  7/106 (6.60%) 
Dysphonia  1  11/85 (12.94%)  14/86 (16.28%)  22/106 (20.75%)  27/106 (25.47%) 
Dyspnoea  1  10/85 (11.76%)  14/86 (16.28%)  15/106 (14.15%)  17/106 (16.04%) 
Epistaxis  1  6/85 (7.06%)  4/86 (4.65%)  4/106 (3.77%)  10/106 (9.43%) 
Oropharyngeal pain  1  5/85 (5.88%)  5/86 (5.81%)  7/106 (6.60%)  4/106 (3.77%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  1/85 (1.18%)  6/86 (6.98%)  3/106 (2.83%)  3/106 (2.83%) 
Dry skin  1  6/85 (7.06%)  6/86 (6.98%)  8/106 (7.55%)  10/106 (9.43%) 
Palmar-plantar erythrodysaesthesia syndrome  1  36/85 (42.35%)  38/86 (44.19%)  61/106 (57.55%)  50/106 (47.17%) 
Pruritus  1  5/85 (5.88%)  3/86 (3.49%)  3/106 (2.83%)  3/106 (2.83%) 
Rash  1  8/85 (9.41%)  12/86 (13.95%)  15/106 (14.15%)  12/106 (11.32%) 
Rash maculo-papular  1  1/85 (1.18%)  5/86 (5.81%)  2/106 (1.89%)  5/106 (4.72%) 
Vascular disorders         
Hypertension  1  18/85 (21.18%)  22/86 (25.58%)  44/106 (41.51%)  42/106 (39.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Substudy 1 was terminated for futility at interim analysis and Substudy 2 was terminated per sponsor decision.
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: NCT02119676     History of Changes
Other Study ID Numbers: INCB18424-267
First Submitted: April 17, 2014
First Posted: April 22, 2014
Results First Submitted: February 10, 2017
Results First Posted: June 14, 2017
Last Update Posted: February 13, 2018