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Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)

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ClinicalTrials.gov Identifier: NCT02959437
Recruitment Status : Terminated (Study terminated by Sponsor)
First Posted : November 9, 2016
Results First Posted : March 5, 2020
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Solid Tumors
Advanced Malignancies
Metastatic Cancer
Interventions Drug: Azacitidine
Drug: Pembrolizumab
Drug: Epacadostat
Drug: INCB057643
Drug: INCB059872
Enrollment 70
Recruitment Details The study was conducted at 8 study sites in United States, 2 sites in UK and 1 site in Spain.
Pre-assignment Details A total of 70 participants were enrolled in the study. Study enrollment was permanently discontinued on 15-Feb-2019 as a strategic decision. No patients were enrolled in Treatment Group B and Treatment Group C.
Arm/Group Title Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360 Treatment Group B :INCB057643+Pembrolizumab+Epacadostat Treatment Group C :INCB059872+Pembrolizumab+Epacadostat
Hide Arm/Group Description In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined. In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg. In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Period Title: Overall Study
Started 62 8 0 [1] 0 [1]
Completed 0 0 0 0
Not Completed 62 8 0 0
Reason Not Completed
Death             33             3             0             0
Lost to Follow-up             3             1             0             0
Withdrawal by Subject             11             3             0             0
Progressive Disease             9             1             0             0
Study Terminated by Sponsor             4             0             0             0
Other Unspecified             2             0             0             0
[1]
Due to early termination of the trial Treatment groups B and C were not dosed.
Arm/Group Title Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360 Treatment Group B :INCB057643+Pembrolizumab+Epacadostat Treatment Group C :INCB059872+Pembrolizumab+Epacadostat Total
Hide Arm/Group Description In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined. In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg. In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Total of all reporting groups
Overall Number of Baseline Participants 62 8 0 0 70
Hide Baseline Analysis Population Description
No patients enrolled in Treatment Group B and C.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 8 participants 0 participants 0 participants 70 participants
57.0  (11.92) 53.0  (11.31) 56.5  (11.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 8 participants 0 participants 0 participants 70 participants
Female
19
  30.6%
4
  50.0%
23
  32.9%
Male
43
  69.4%
4
  50.0%
47
  67.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 8 participants 0 participants 0 participants 70 participants
White/Caucasian
56
  90.3%
5
  62.5%
61
  87.1%
Black/African-American
3
   4.8%
0
   0.0%
3
   4.3%
Asian
2
   3.2%
0
   0.0%
2
   2.9%
American-Indian/Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian/Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Other
1
   1.6%
3
  37.5%
4
   5.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 62 participants 8 participants 0 participants 0 participants 70 participants
Hispanic or Latino
4
   6.5%
2
  25.0%
0 0
6
   8.6%
Not Hispanic or Latino
54
  87.1%
6
  75.0%
0 0
60
  85.7%
Unknown
4
   6.5%
0
   0.0%
0 0
4
   5.7%
1.Primary Outcome
Title Part 1 and 2 : Number of Participants With Treatment Emergent Adverse Events
Hide Description A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. 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 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population includes all subjects enrolled in the study who received at least 1 dose of study drug.
Arm/Group Title Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360 Treatment Group B :INCB057643+Pembrolizumab+Epacadostat Treatment Group C :INCB059872+Pembrolizumab+Epacadostat
Hide Arm/Group Description:
In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Overall Number of Participants Analyzed 62 8 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
62
 100.0%
8
 100.0%
2.Primary Outcome
Title Part 1 and 2: Objective Response Rate Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Hide Description ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A participant was considered as an objective responder if the participant had a best overall response of CR or PR.
Time Frame Every 9 weeks for the duration of study participation; estimated minimum of 6 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The response evaluable population includes all subjects enrolled in the study who received at least 1 dose of study drug, completed a baseline scan and have at least 1 post baseline scan, or has been on study for a minimum of 70 days of follow-up or who discontinued treatment. No participants enrolled in part 2 of the study due to early termination of study
Arm/Group Title Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360 Treatment Group B :INCB057643+Pembrolizumab+Epacadostat Treatment Group C :INCB059872+Pembrolizumab+Epacadostat
Hide Arm/Group Description:
In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Overall Number of Participants Analyzed 62 8 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.8%
1
  12.5%
0 0
3.Secondary Outcome
Title Parts 1 and 2: Percentage of Responders Determined by Immunohistochemistry
Hide Description Responder is defined as an increase in the number of tumor-infiltrating lymphocytes or the ratio of CD8+ lymphocytes to T regulatory cells infiltrating tumor post-treatment versus pretreatment with pembrolizumab and epacadostat in combination with azacitidine.
Time Frame Baseline to Week 5/6 or week 8/9
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled in the study who received at least 1 dose of study drug, who had evaluable baseline and on treatment biopsies. No participants enrolled in part 2 of the study due to early termination of study.
Arm/Group Title Treatment Group A :100 or 300mg of INCB24360 Treatment Group B :INCB057643+Pembrolizumab+Epacadostat Treatment Group C :INCB059872+Pembrolizumab+Epacadostat
Hide Arm/Group Description:
Treatment Group A :100mg of INCB24360 In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg or 300mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Overall Number of Participants Analyzed 19 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Intratumoral CD8+ T cells
14
  73.7%
CD8+:FoxP3+ ratios
10
  52.6%
4.Secondary Outcome
Title Parts 1 and 2: Progression-free Survival Based on RECIST v1.1.
Hide Description Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Time Frame Every 9 weeks from date of randomization until the date of first documented progression or date of death from any cause whichever came first, assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled in the study who received at least 1 dose of study drug, completed a baseline scan and have at least 1 post baseline scan, or has been on study for a minimum of 70 days of follow-up or who discontinued treatment. No participants enrolled in part 2 of the study due to early termination of study
Arm/Group Title Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360 Treatment Group B :INCB057643+Pembrolizumab+Epacadostat Treatment Group C :INCB059872+Pembrolizumab+Epacadostat
Hide Arm/Group Description:
In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Overall Number of Participants Analyzed 62 8 0 0
Median (95% Confidence Interval)
Unit of Measure: Months
2.07
(1.97 to 2.17)
2.64
(1.31 to 6.11)
5.Secondary Outcome
Title Parts 1 and 2: Duration of Response Based on RECIST v1.1
Hide Description Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Time Frame Every 9 weeks from date of randomization until the date of first documented progression or date of death from any cause whichever came first, assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects enrolled in the study who received at least 1 dose of study drug, completed a baseline scan and have at least 1 post baseline scan, or has been on study for a minimum of 70 days of follow-up or who discontinued treatment. No participants enrolled in part 2 of the study due to early termination of study.
Arm/Group Title Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360 Treatment Group B :INCB057643+Pembrolizumab+Epacadostat Treatment Group C :INCB059872+Pembrolizumab+Epacadostat
Hide Arm/Group Description:
In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined.
In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
In Treatment Group B, subjects will receive INCB057643 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
In Treatment Group C, subjects will receive INCB059872 in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg.
Overall Number of Participants Analyzed 3 1 0 0
Median (95% Confidence Interval)
Unit of Measure: Months
2.63
(2.20 to 21.85)
1.22 [1] 
(NA to NA)
[1]
Upper and Lower bound not estimable due to 1 responder in the treatment arm.
Time Frame Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).
Adverse Event Reporting Description The safety population included all participants enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups B and C.
 
Arm/Group Title Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
Hide Arm/Group Description In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 100mg. Due to early termination of study subjects from dose escalation and dose expansion are combined. In Treatment Group A, subjects will receive the DNMT inhibitor azacitidine in combination with the PD-1 inhibitor pembrolizumab and the IDO1 inhibitor epacadostat at 300mg.
All-Cause Mortality
Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
Affected / at Risk (%) Affected / at Risk (%)
Total   41/62 (66.13%)   4/8 (50.00%) 
Hide Serious Adverse Events
Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
Affected / at Risk (%) Affected / at Risk (%)
Total   28/62 (45.16%)   3/8 (37.50%) 
Blood and lymphatic system disorders     
Anemia  1  2/62 (3.23%)  0/8 (0.00%) 
Leukocytosis  1  0/62 (0.00%)  1/8 (12.50%) 
Cardiac disorders     
Atrial fibrillation  1  1/62 (1.61%)  0/8 (0.00%) 
Sinua tachycardia  1  0/62 (0.00%)  1/8 (12.50%) 
Endocrine disorders     
Hyperthyroidism  1  1/62 (1.61%)  0/8 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  1  2/62 (3.23%)  1/8 (12.50%) 
Ascites  1  1/62 (1.61%)  0/8 (0.00%) 
Diarrhoea  1  1/62 (1.61%)  0/8 (0.00%) 
Intra-abdominal haemorrhage  1  1/62 (1.61%)  0/8 (0.00%) 
Intussusception  1  1/62 (1.61%)  0/8 (0.00%) 
Nausea  1  4/62 (6.45%)  1/8 (12.50%) 
Small Intestinal Obstruction  1  3/62 (4.84%)  0/8 (0.00%) 
Vomiting  1  2/62 (3.23%)  1/8 (12.50%) 
General disorders     
Asthenia  1  0/62 (0.00%)  1/8 (12.50%) 
Disease Progression  1  8/62 (12.90%)  0/8 (0.00%) 
Fatigue  1  2/62 (3.23%)  0/8 (0.00%) 
Non-cardiac Chest Pain  1  0/62 (0.00%)  1/8 (12.50%) 
Pain  1  1/62 (1.61%)  0/8 (0.00%) 
Pyrexia  1  1/62 (1.61%)  0/8 (0.00%) 
Infections and infestations     
Infection  1  0/62 (0.00%)  1/8 (12.50%) 
Urinary tract Infection  1  1/62 (1.61%)  0/8 (0.00%) 
Injury, poisoning and procedural complications     
Head Injury  1  0/62 (0.00%)  1/8 (12.50%) 
Wound Haemorrhage  1  0/62 (0.00%)  1/8 (12.50%) 
Metabolism and nutrition disorders     
Dehydration  1  1/62 (1.61%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  3/62 (4.84%)  0/8 (0.00%) 
Bone Pain  1  1/62 (1.61%)  0/8 (0.00%) 
Muscular Weakness  1  1/62 (1.61%)  0/8 (0.00%) 
Pain in Extremity  1  1/62 (1.61%)  0/8 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant Neoplasm Progression  1  1/62 (1.61%)  0/8 (0.00%) 
Rectal Cancer Metastatic  1  1/62 (1.61%)  0/8 (0.00%) 
Lymphangiosis Carcinomatosa  1  1/62 (1.61%)  0/8 (0.00%) 
Nervous system disorders     
Brain Injury  1  1/62 (1.61%)  0/8 (0.00%) 
Brain Oedema  1  1/62 (1.61%)  0/8 (0.00%) 
Dizziness  1  0/62 (0.00%)  1/8 (12.50%) 
Dysmetria  1  1/62 (1.61%)  0/8 (0.00%) 
Headache  1  1/62 (1.61%)  0/8 (0.00%) 
Hemiparesis  1  1/62 (1.61%)  0/8 (0.00%) 
Hypoaesthesia  1  1/62 (1.61%)  0/8 (0.00%) 
Loss of Consciousness  1  0/62 (0.00%)  1/8 (12.50%) 
Peroneal Nerve Palsy  1  1/62 (1.61%)  0/8 (0.00%) 
Seizure  1  2/62 (3.23%)  0/8 (0.00%) 
Psychiatric disorders     
Confusional State  1  1/62 (1.61%)  1/8 (12.50%) 
Mental Status Changes  1  1/62 (1.61%)  0/8 (0.00%) 
Renal and urinary disorders     
Urinary Retention  1  1/62 (1.61%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  1  1/62 (1.61%)  0/8 (0.00%) 
Cough  1  1/62 (1.61%)  0/8 (0.00%) 
Dyspnoea  1  1/62 (1.61%)  0/8 (0.00%) 
Haemoptysis  1  1/62 (1.61%)  0/8 (0.00%) 
Hypoxia  1  1/62 (1.61%)  0/8 (0.00%) 
Pneumonitis  1  1/62 (1.61%)  0/8 (0.00%) 
Pulmonary Embolism  1  1/62 (1.61%)  0/8 (0.00%) 
Respiratory Failure  1  1/62 (1.61%)  0/8 (0.00%) 
1
Term from vocabulary, 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group A :100mg of INCB24360 Treatment Group A :300mg of INCB24360
Affected / at Risk (%) Affected / at Risk (%)
Total   59/62 (95.16%)   8/8 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  11/62 (17.74%)  2/8 (25.00%) 
Cardiac disorders     
Sinus Tachycardia  1  0/62 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders     
Abdominal Distension  1  2/62 (3.23%)  2/8 (25.00%) 
Abdominal pain  1  12/62 (19.35%)  1/8 (12.50%) 
Abdominal pain lower  1  1/62 (1.61%)  1/8 (12.50%) 
Constipation  1  16/62 (25.81%)  3/8 (37.50%) 
Dyspepsia  1  3/62 (4.84%)  1/8 (12.50%) 
Gastrooesophageal reflux disease  1  4/62 (6.45%)  1/8 (12.50%) 
Nausea  1  34/62 (54.84%)  3/8 (37.50%) 
Vomiting  1  21/62 (33.87%)  2/8 (25.00%) 
Diarrhoea  1  12/62 (19.35%)  3/8 (37.50%) 
General disorders     
Chills  1  4/62 (6.45%)  1/8 (12.50%) 
Fatigue  1  28/62 (45.16%)  6/8 (75.00%) 
Injection site erythema  1  5/62 (8.06%)  0/8 (0.00%) 
Injection site pain  1  4/62 (6.45%)  0/8 (0.00%) 
Injection site reaction  1  13/62 (20.97%)  0/8 (0.00%) 
Local swelling  1  1/62 (1.61%)  1/8 (12.50%) 
Oedema peripheral  1  6/62 (9.68%)  1/8 (12.50%) 
Pyrexia  1  6/62 (9.68%)  0/8 (0.00%) 
Infections and infestations     
Herpes zoster  1  0/62 (0.00%)  1/8 (12.50%) 
Mastoiditis  1  0/62 (0.00%)  1/8 (12.50%) 
Upper respiratory tract infection  1  3/62 (4.84%)  1/8 (12.50%) 
Injury, poisoning and procedural complications     
Ligament sprain  1  0/62 (0.00%)  1/8 (12.50%) 
Investigations     
Alanine aminotransferase increased  1  4/62 (6.45%)  2/8 (25.00%) 
Aspartate aminotransferase increased  1  5/62 (8.06%)  3/8 (37.50%) 
Blood alkaline phosphatase increased  1  7/62 (11.29%)  2/8 (25.00%) 
Blood creatinine increased  1  4/62 (6.45%)  0/8 (0.00%) 
Blood phosphorus decreased  1  0/62 (0.00%)  1/8 (12.50%) 
Electrocardiogram QT prolonged  1  0/62 (0.00%)  1/8 (12.50%) 
Platelet count decreased  1  2/62 (3.23%)  1/8 (12.50%) 
White blood cell count decreased  1  3/62 (4.84%)  1/8 (12.50%) 
Metabolism and nutrition disorders     
Decreased appetite  1  12/62 (19.35%)  5/8 (62.50%) 
Hypercalcaemia  1  0/62 (0.00%)  1/8 (12.50%) 
Hyperkalaemia  1  4/62 (6.45%)  0/8 (0.00%) 
Hypoalbuminaemia  1  4/62 (6.45%)  1/8 (12.50%) 
Hypokalaemia  1  4/62 (6.45%)  0/8 (0.00%) 
Hypomagnesaemia  1  0/62 (0.00%)  1/8 (12.50%) 
Hyponatraemia  1  3/62 (4.84%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/62 (11.29%)  1/8 (12.50%) 
Back pain  1  6/62 (9.68%)  2/8 (25.00%) 
Flank pain  1  1/62 (1.61%)  1/8 (12.50%) 
Muscle spasms  1  1/62 (1.61%)  1/8 (12.50%) 
Musculoskeletal chest pain  1  2/62 (3.23%)  1/8 (12.50%) 
Musculoskeletal discomfort  1  0/62 (0.00%)  1/8 (12.50%) 
Musculoskeletal pain  1  0/62 (0.00%)  2/8 (25.00%) 
Myalgia  1  4/62 (6.45%)  2/8 (25.00%) 
Neck pain  1  1/62 (1.61%)  1/8 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/62 (1.61%)  1/8 (12.50%) 
Nervous system disorders     
Headache  1  4/62 (6.45%)  4/8 (50.00%) 
Neuropathy peripheral  1  2/62 (3.23%)  1/8 (12.50%) 
Peroneal nerve palsy  1  0/62 (0.00%)  1/8 (12.50%) 
Psychiatric disorders     
Anxiety  1  3/62 (4.84%)  1/8 (12.50%) 
Insomnia  1  5/62 (8.06%)  1/8 (12.50%) 
Renal and urinary disorders     
Haematuria  1  0/62 (0.00%)  1/8 (12.50%) 
Pneumaturia  1  0/62 (0.00%)  1/8 (12.50%) 
Terminal dribbling  1  0/62 (0.00%)  1/8 (12.50%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  9/62 (14.52%)  2/8 (25.00%) 
Dyspnoea  1  8/62 (12.90%)  1/8 (12.50%) 
Dyspnoea exertional  1  4/62 (6.45%)  0/8 (0.00%) 
Productive cough  1  2/62 (3.23%)  2/8 (25.00%) 
Wheezing  1  0/62 (0.00%)  1/8 (12.50%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/62 (0.00%)  1/8 (12.50%) 
Dermatitis acneiform  1  0/62 (0.00%)  1/8 (12.50%) 
Pruritus  1  6/62 (9.68%)  1/8 (12.50%) 
Rash  1  9/62 (14.52%)  2/8 (25.00%) 
Vascular disorders     
Hypotension  1  2/62 (3.23%)  1/8 (12.50%) 
1
Term from vocabulary, 19.1
Indicates events were collected by systematic assessment
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.
Clinical Study Agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Incyte Corporation
Phone: 1-855-463-3463
EMail: medinfo@incyte.com
Layout table for additonal information
Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02959437    
Other Study ID Numbers: INCB 24360-206 / ECHO-206
First Submitted: November 7, 2016
First Posted: November 9, 2016
Results First Submitted: February 14, 2020
Results First Posted: March 5, 2020
Last Update Posted: May 6, 2021