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A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

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: NCT02120417
Recruitment Status : Terminated (The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.)
First Posted : April 22, 2014
Results First Posted : July 12, 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 Breast Cancer
Interventions Drug: Ruxolitinib
Drug: Capecitabine
Drug: Placebo
Enrollment 149
Recruitment Details This study was conducted at 72 study centers (65 in the United States and 7 in the European Union [3 in the United Kingdom, 3 in Spain, and 1 in Portugal]).
Pre-assignment Details  
Arm/Group Title Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Period Title: Overall Study
Started [1] 76 73
Completed [2] 16 5
Not Completed 60 68
Reason Not Completed
Death             5             1
Adverse Event             3             9
Participant decision             4             4
Disease progression             41             45
Noncompliance with study treatment             0             2
Physician Decision             2             3
Other unspecified             5             4
[1]
Overall Number of Participants Analyzed
[2]
Number of participants remaining on treatment at the 08 FEB 2016 data cutoff.
Arm/Group Title Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo Total
Hide Arm/Group Description Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle Total of all reporting groups
Overall Number of Baseline Participants 76 73 149
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 76 participants 73 participants 149 participants
54.3  (11.00) 55.0  (12.75) 54.6  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 73 participants 149 participants
Female
76
 100.0%
73
 100.0%
149
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.
Time Frame Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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 Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description:
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Overall Number of Participants Analyzed 76 73
Measure Type: Count of Participants
Unit of Measure: Participants
Death events
39
  51.3%
38
  52.1%
Censored events
37
  48.7%
35
  47.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment A - Capecitabine and Ruxolitinib, Treatment B - Capecitabine and Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.762
Comments [Not Specified]
Method Log Rank
Comments The P-value was analyzed by Log-Rank Test stratified by Hormone Receptor Status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.932
Confidence Interval (2-Sided) 80%
0.694 to 1.252
Estimation Comments [Not Specified]
2.Primary Outcome
Title Median Survival
Hide Description Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Time Frame Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
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 Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description:
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Overall Number of Participants Analyzed 76 73
Median (95% Confidence Interval)
Unit of Measure: months
11.2
(7.5 to 12.7)
10.9
(6.0 to 13.1)
3.Primary Outcome
Title Percentage of Participants Achieving Overall Survival
Hide Description Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Time Frame Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
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 Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description:
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Overall Number of Participants Analyzed 76 73
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 3 Survival Rate
0.855
(0.753 to 0.917)
0.750
(0.633 to 0.835)
Month 6 Survival Rate
0.674
(0.554 to 0.769)
0.635
(0.511 to 0.735)
Month 9 Survival Rate
0.537
(0.404 to 0.652)
0.546
(0.417 to 0.657)
Month 12 Survival Rate
0.435
(0.289 to 0.573)
0.427
(0.286 to 0.561)
Month 15 Survival Rate
0.319
(0.174 to 0.475)
0.294
(0.148 to 0.456)
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.
Time Frame Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
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 Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description:
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Overall Number of Participants Analyzed 76 73
Median (95% Confidence Interval)
Unit of Measure: months
4.5
(2.3 to 6.1)
2.5
(2.1 to 4.1)
5.Secondary Outcome
Title Percentage of Participants Achieving Objective Response Rate
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 Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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 Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description:
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Overall Number of Participants Analyzed 76 73
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response rate 0.0 0.0
Partial Response rate 28.9 13.7
6.Secondary Outcome
Title Duration of Response (DOR)
Hide Description The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. 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 Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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 Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description:
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Overall Number of Participants Analyzed 76 73
Median (80% Confidence Interval)
Unit of Measure: months
4.2
(3.5 to 4.6)
4.4
(3.8 to 6.4)
7.Secondary Outcome
Title Percentage of Participants Achieving Clinical Benefit Rate
Hide Description Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. 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 Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
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 Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description:
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
Overall Number of Participants Analyzed 76 73
Measure Type: Number
Unit of Measure: percentage of participants
13.2 6.8
Time Frame Participants received study treatment in continuous 21-day cycles until they met withdrawal criteria up to 19 months or the data cutoff 08FEB2016. The cutoff date of 08Feb2016 was chosen based on the date that the sponsor became aware that the seventieth death had occurred in the randomized population.
Adverse Event Reporting Description

The safety evaluable population consisted of all participants enrolled in the study who received at least 1 dose of any study treatment (ie, ruxolitinib, placebo, or capecitabine).

Adverse events were collected from participants and tabulated by the MedDRA version 17.0 preferred term and system organ class (SOC).The intensity and whether treatment related was tabulated and reported by the investigator.

 
Arm/Group Title Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Hide Arm/Group Description Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of Ruxolitinib 15 mg (three 5 mg tablets) BID to be administered by mouth on day 1 to day 21 of each 21-day cycle Capecitabine given as 1000 mg/m^2 twice a day (BID) on day 1 to day 14 of each 21-day cycle with the addition of 15 mg (three 5 mg tablets) matching placebo BID to be administered by mouth on day 1 to day 21 of each 21-day cycle
All-Cause Mortality
Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   28/71 (39.44%)   29/71 (40.85%) 
Blood and lymphatic system disorders     
Anaemia  1  1/71 (1.41%)  1/71 (1.41%) 
Febrile neutropenia  1  1/71 (1.41%)  1/71 (1.41%) 
Neutropenia  1  2/71 (2.82%)  0/71 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/71 (0.00%)  1/71 (1.41%) 
Cardiac arrest  1  1/71 (1.41%)  0/71 (0.00%) 
Cardiac failure  1  1/71 (1.41%)  0/71 (0.00%) 
Cardiac failure congestive  1  0/71 (0.00%)  1/71 (1.41%) 
Pericardial effusion  1  0/71 (0.00%)  1/71 (1.41%) 
Supraventricular tachycardia  1  1/71 (1.41%)  0/71 (0.00%) 
Tachycardia  1  1/71 (1.41%)  1/71 (1.41%) 
Gastrointestinal disorders     
Abdominal pain  1  2/71 (2.82%)  1/71 (1.41%) 
Abdominal pain lower  1  1/71 (1.41%)  0/71 (0.00%) 
Abdominal pain upper  1  1/71 (1.41%)  0/71 (0.00%) 
Ascites  1  0/71 (0.00%)  2/71 (2.82%) 
Colitis  1  1/71 (1.41%)  1/71 (1.41%) 
Constipation  1  1/71 (1.41%)  2/71 (2.82%) 
Diarrhoea  1  2/71 (2.82%)  1/71 (1.41%) 
Enterocolitis haemorrhagic  1  1/71 (1.41%)  0/71 (0.00%) 
Nausea  1  5/71 (7.04%)  1/71 (1.41%) 
Small intestinal obstruction  1  1/71 (1.41%)  0/71 (0.00%) 
Stomatitis  1  1/71 (1.41%)  0/71 (0.00%) 
Vomiting  1  4/71 (5.63%)  4/71 (5.63%) 
General disorders     
Non-cardiac chest pain  1  2/71 (2.82%)  1/71 (1.41%) 
Oedema  1  0/71 (0.00%)  1/71 (1.41%) 
Pain  1  0/71 (0.00%)  1/71 (1.41%) 
Pyrexia  1  2/71 (2.82%)  2/71 (2.82%) 
Hepatobiliary disorders     
Hepatic failure  1  2/71 (2.82%)  1/71 (1.41%) 
Hyperbilirubinaemia  1  1/71 (1.41%)  0/71 (0.00%) 
Infections and infestations     
Bronchitis  1  1/71 (1.41%)  0/71 (0.00%) 
Clostridium difficile colitis  1  0/71 (0.00%)  1/71 (1.41%) 
Clostridium difficile infection  1  1/71 (1.41%)  0/71 (0.00%) 
Diverticulitis  1  0/71 (0.00%)  1/71 (1.41%) 
Lung infection  1  1/71 (1.41%)  0/71 (0.00%) 
Pneumonia  1  3/71 (4.23%)  1/71 (1.41%) 
Sepsis  1  2/71 (2.82%)  2/71 (2.82%) 
Urinary tract infection  1  2/71 (2.82%)  1/71 (1.41%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/71 (1.41%)  0/71 (0.00%) 
Hip fracture  1  1/71 (1.41%)  0/71 (0.00%) 
Humerus fracture  1  0/71 (0.00%)  1/71 (1.41%) 
Investigations     
Blood bilirubin increased  1  0/71 (0.00%)  1/71 (1.41%) 
Blood creatinine increased  1  1/71 (1.41%)  0/71 (0.00%) 
Platelet count decreased  1  2/71 (2.82%)  1/71 (1.41%) 
Metabolism and nutrition disorders     
Dehydration  1  3/71 (4.23%)  1/71 (1.41%) 
Hypoglycaemia  1  0/71 (0.00%)  1/71 (1.41%) 
Hypokalaemia  1  1/71 (1.41%)  1/71 (1.41%) 
Hyponatraemia  1  1/71 (1.41%)  0/71 (0.00%) 
Lactic acidosis  1  1/71 (1.41%)  0/71 (0.00%) 
Metabolic acidosis  1  1/71 (1.41%)  0/71 (0.00%) 
Metabolic disorder  1  1/71 (1.41%)  0/71 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/71 (1.41%)  0/71 (0.00%) 
Bone pain  1  2/71 (2.82%)  1/71 (1.41%) 
Pain in extremity  1  0/71 (0.00%)  1/71 (1.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant pleural effusion  1  0/71 (0.00%)  1/71 (1.41%) 
Metastases to meninges  1  1/71 (1.41%)  0/71 (0.00%) 
Nervous system disorders     
Embolic stroke  1  0/71 (0.00%)  1/71 (1.41%) 
Encephalopathy  1  0/71 (0.00%)  1/71 (1.41%) 
Headache  1  1/71 (1.41%)  0/71 (0.00%) 
Hepatic encephalopathy  1  1/71 (1.41%)  0/71 (0.00%) 
Spinal cord compression  1  0/71 (0.00%)  2/71 (2.82%) 
Syncope  1  1/71 (1.41%)  0/71 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/71 (1.41%)  0/71 (0.00%) 
Mental status changes  1  0/71 (0.00%)  1/71 (1.41%) 
Renal and urinary disorders     
Hydronephrosis  1  1/71 (1.41%)  0/71 (0.00%) 
Renal failure acute  1  1/71 (1.41%)  0/71 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/71 (0.00%)  1/71 (1.41%) 
Dyspnoea  1  3/71 (4.23%)  4/71 (5.63%) 
Haemoptysis  1  1/71 (1.41%)  0/71 (0.00%) 
Hypoxia  1  2/71 (2.82%)  1/71 (1.41%) 
Pleural effusion  1  3/71 (4.23%)  6/71 (8.45%) 
Pleuritic pain  1  0/71 (0.00%)  1/71 (1.41%) 
Pulmonary embolism  1  1/71 (1.41%)  1/71 (1.41%) 
Respiratory distress  1  0/71 (0.00%)  2/71 (2.82%) 
Respiratory failure  1  0/71 (0.00%)  2/71 (2.82%) 
Vascular disorders     
Deep vein thrombosis  1  0/71 (0.00%)  3/71 (4.23%) 
Embolism  1  1/71 (1.41%)  2/71 (2.82%) 
Hypertension  1  1/71 (1.41%)  0/71 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment A - Capecitabine and Ruxolitinib Treatment B - Capecitabine and Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   69/71 (97.18%)   69/71 (97.18%) 
Blood and lymphatic system disorders     
Anaemia  1  35/71 (49.30%)  18/71 (25.35%) 
Neutropenia  1  9/71 (12.68%)  5/71 (7.04%) 
Thrombocytopenia  1  6/71 (8.45%)  1/71 (1.41%) 
Cardiac disorders     
Tachycardia  1  6/71 (8.45%)  3/71 (4.23%) 
Gastrointestinal disorders     
Abdominal distension  1  5/71 (7.04%)  6/71 (8.45%) 
Abdominal pain  1  12/71 (16.90%)  6/71 (8.45%) 
Constipation  1  18/71 (25.35%)  17/71 (23.94%) 
Diarrhoea  1  33/71 (46.48%)  19/71 (26.76%) 
Dyspepsia  1  6/71 (8.45%)  4/71 (5.63%) 
Gastrooesophageal reflux disease  1  4/71 (5.63%)  4/71 (5.63%) 
Nausea  1  39/71 (54.93%)  35/71 (49.30%) 
Stomatitis  1  19/71 (26.76%)  12/71 (16.90%) 
Vomiting  1  26/71 (36.62%)  19/71 (26.76%) 
General disorders     
Fatigue  1  40/71 (56.34%)  31/71 (43.66%) 
Oedema  1  4/71 (5.63%)  3/71 (4.23%) 
Pyrexia  1  12/71 (16.90%)  10/71 (14.08%) 
Oedema peripheral  1  10/71 (14.08%)  14/71 (19.72%) 
Infections and infestations     
Upper respiratory tract infection  1  4/71 (5.63%)  2/71 (2.82%) 
Urinary tract infection  1  6/71 (8.45%)  6/71 (8.45%) 
Investigations     
Alanine aminotransferase increased  1  6/71 (8.45%)  4/71 (5.63%) 
Aspartate aminotransferase increased  1  9/71 (12.68%)  5/71 (7.04%) 
Blood alkaline phosphatase increased  1  5/71 (7.04%)  4/71 (5.63%) 
Blood creatinine increased  1  5/71 (7.04%)  3/71 (4.23%) 
Lymphocyte count decreased  1  4/71 (5.63%)  2/71 (2.82%) 
Neutrophil count decreased  1  6/71 (8.45%)  2/71 (2.82%) 
Platelet count decreased  1  6/71 (8.45%)  0/71 (0.00%) 
Weight decreased  1  4/71 (5.63%)  5/71 (7.04%) 
Weight increased  1  6/71 (8.45%)  4/71 (5.63%) 
White blood cell count decreased  1  7/71 (9.86%)  1/71 (1.41%) 
Metabolism and nutrition disorders     
Decreased appetite  1  21/71 (29.58%)  19/71 (26.76%) 
Dehydration  1  11/71 (15.49%)  3/71 (4.23%) 
Hypocalcaemia  1  8/71 (11.27%)  0/71 (0.00%) 
Hypokalaemia  1  10/71 (14.08%)  5/71 (7.04%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/71 (9.86%)  9/71 (12.68%) 
Back pain  1  11/71 (15.49%)  5/71 (7.04%) 
Muscle spasms  1  5/71 (7.04%)  3/71 (4.23%) 
Muscular weakness  1  5/71 (7.04%)  2/71 (2.82%) 
Musculoskeletal chest pain  1  3/71 (4.23%)  5/71 (7.04%) 
Musculoskeletal pain  1  4/71 (5.63%)  5/71 (7.04%) 
Myalgia  1  5/71 (7.04%)  2/71 (2.82%) 
Neck pain  1  4/71 (5.63%)  2/71 (2.82%) 
Pain in extremity  1  9/71 (12.68%)  5/71 (7.04%) 
Nervous system disorders     
Dizziness  1  13/71 (18.31%)  13/71 (18.31%) 
Dysgeusia  1  1/71 (1.41%)  5/71 (7.04%) 
Headache  1  16/71 (22.54%)  9/71 (12.68%) 
Hypoaesthesia  1  4/71 (5.63%)  4/71 (5.63%) 
Neuropathy peripheral  1  3/71 (4.23%)  5/71 (7.04%) 
Peripheral sensory neuropathy  1  4/71 (5.63%)  5/71 (7.04%) 
Psychiatric disorders     
Anxiety  1  1/71 (1.41%)  6/71 (8.45%) 
Insomnia  1  8/71 (11.27%)  9/71 (12.68%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  14/71 (19.72%)  9/71 (12.68%) 
Dyspnoea  1  22/71 (30.99%)  20/71 (28.17%) 
Epistaxis  1  5/71 (7.04%)  2/71 (2.82%) 
Oropharyngeal pain  1  4/71 (5.63%)  1/71 (1.41%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  4/71 (5.63%)  0/71 (0.00%) 
Dry skin  1  3/71 (4.23%)  5/71 (7.04%) 
Palmar-plantar erythrodysaesthesia syndrome  1  33/71 (46.48%)  27/71 (38.03%) 
Skin hyperpigmentation  1  6/71 (8.45%)  2/71 (2.82%) 
Vascular disorders     
Hot flush  1  4/71 (5.63%)  1/71 (1.41%) 
Hypertension  1  4/71 (5.63%)  2/71 (2.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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: 855 463-3463
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02120417    
Other Study ID Numbers: INCB 18424-268
First Submitted: April 18, 2014
First Posted: April 22, 2014
Results First Submitted: February 6, 2017
Results First Posted: July 12, 2017
Last Update Posted: February 13, 2018