Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma

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: NCT02860286
Recruitment Status : Completed
First Posted : August 9, 2016
Results First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Epizyme, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mesothelioma
BAP1 Loss of Function
Intervention Drug: Tazemetostat
Enrollment 74
Recruitment Details

Study EZH-203 was conducted at 16 clinical sites in France, UK, and USA. Subjects were screened for eligibility within 21 days of the planned date of the first dose of tazemetostat.

Eligible subjects were enrolled into 2 different parts:

  • Part 1 - Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status
  • Part 2 - Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma.
Pre-assignment Details

Seventy-four subjects were enrolled and treated with study drug (13 subjects in Part 1 and 61 subjects in Part 2).

No patients were excluded due to unmet study eligibility criteria.

Arm/Group Title Part 1 (Pharmacokinetics) Part 2 (Efficacy)
Hide Arm/Group Description Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status were to be treated and PK blood samples collected after a single tazemetostat 800 mg dose on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Subjects were to receive a single oral 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was orally administered at a dose of 800 mg twice daily. subjects with BAP1-deficient relapsed or refractory malignant mesothelioma were to receive orally administered tazemetostat 800 mg twice daily starting on Cycle 1 Day 1.
Period Title: Overall Study
Started 13 61
Completed 13 61
Not Completed 0 0
Arm/Group Title Part 1 (Pharmacokenitc) Part 2 (Efficacy) Total
Hide Arm/Group Description Subjects enrolled in Part 1were to receive a single 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was to be administered at a dose of 800 mg twice daily. PK blood samples were to be collected after administration of a single dose of 800 mg tazemetostat on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Plasma samples were to be analyzed for tazemetostat after each set of 6 subjects completed the PK sampling procedures on Cycle 1 Day 15.

In Part 2, subjects with BAP1-deficient relapsed or refractory malignant mesothelioma were to receive orally administered tazemetostat 800 mg twice daily starting on Cycle 1 Day 1.

A 2-stage Green-Dahlberg design was utilized with a stopping rule to allow early termination at the end of Stage 1 if there was strong evidence of lack of efficacy based on results from the first 30 treated subjects who completed at least the 12-week assessment, completed the final study visit, or terminated early from the study, whichever was sooner. If early stopping criteria were met, enrollment was to be stopped. To avoid disruptions in the study, enrollment and treatment of subjects were not halted in order to conduct the interim analysis.

Total of all reporting groups
Overall Number of Baseline Participants 13 61 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 61 participants 74 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  46.2%
37
  60.7%
43
  58.1%
>=65 years
7
  53.8%
24
  39.3%
31
  41.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 61 participants 74 participants
64.7  (8.58) 65.1  (10.56) 65.0  (10.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 61 participants 74 participants
Female
3
  23.1%
22
  36.1%
25
  33.8%
Male
10
  76.9%
39
  63.9%
49
  66.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 61 participants 74 participants
Hispanic or Latino
2
  15.4%
2
   3.3%
4
   5.4%
Not Hispanic or Latino
5
  38.5%
44
  72.1%
49
  66.2%
Other
6
  46.2%
15
  24.6%
21
  28.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 61 participants 74 participants
United States 8 15 23
United Kingdom 2 35 37
France 3 11 14
Baseline Disease Characteristics and Prior Therapies  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 61 participants 74 participants
Solid Tumor with 1 prior line of systemic Anticancer Therapy
3
  23.1%
27
  44.3%
30
  40.5%
Solid Tumor with 2 prior lines of systemic Anticancer Therapy
7
  53.8%
13
  21.3%
20
  27.0%
Solid Tumor with 3 prior lines of systemic Anticancer Therapy
1
   7.7%
14
  23.0%
15
  20.3%
Solid Tumor with 4 prior lines of systemic Anticancer Therapy
1
   7.7%
1
   1.6%
2
   2.7%
Solid Tumor with >=5 prior lines of systemic Anticancer Therapy
1
   7.7%
6
   9.8%
7
   9.5%
1.Primary Outcome
Title Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): Cmax
Hide Description To assess the pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status.
Time Frame Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 12 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 (Pharmacokinetics)
Hide Arm/Group Description:
Assessment of pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Ng/mL
933  (440)
2.Primary Outcome
Title Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): Tmax
Hide Description [Not Specified]
Time Frame Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and12 post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 (Pharmacokinetics)
Hide Arm/Group Description:
Assessment of pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status.
Overall Number of Participants Analyzed 13
Median (Inter-Quartile Range)
Unit of Measure: Hour
1.1
(1 to 4)
3.Primary Outcome
Title Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): AUC(0-t)
Hide Description To assess the pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status
Time Frame Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and12 post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 (Pharmacokinetics)
Hide Arm/Group Description:
Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status were to be treated and PK blood samples collected after a single tazemetostat 800 mg dose on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Subjects were to receive a single oral 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was orally administered at a dose of 800 mg twice daily.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
3650  (1640)
4.Primary Outcome
Title Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): AUC(0-∞)
Hide Description Pharmacokinetics profile of tazemetostat and its metabolite (plasma) assessing AUC(0-∞)
Time Frame Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 12 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 (Pharmacokinetics)
Hide Arm/Group Description:
Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status were to be treated and PK blood samples collected after a single tazemetostat 800 mg dose on Cycle 1 Day 1 and after repeated twice daily doses of tazemetostat 800 mg on Cycle 1 Day 15. Subjects were to receive a single oral 800 mg tazemetostat dose on Cycle 1 Day 1. Starting on Cycle 1 Day 2, tazemetostat was orally administered at a dose of 800 mg twice daily.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
3410  (1640)
5.Primary Outcome
Title Part 1: Pharmacokinetics Profile of Tazemetostat and Its Metabolite (Plasma): t1/2
Hide Description Results from assessing the half-life of Tazemetostat and its metabolite shown below
Time Frame Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 12 post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1(Pharmacokinetics)
Hide Arm/Group Description:

Oral Tazemetostat 800mg BID

Tazemetostat: Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Hour
3.06  (0.307)
6.Primary Outcome
Title Part 2: To Assess Disease Control Rate (DCR) Defined as Number of Subjects With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Hide Description Overall, the disease control rate (DCR) (calculated as subjects with CR + subjects with PR + subjects with SD at 12 weeks in duration), and the DCR at 24 weeks.
Time Frame The patients were assessed for DCR for up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 2
Hide Arm/Group Description:
Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma.
Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
DCR at 12 weeks
33
  54.1%
DCR at 24 weeks
20
  32.8%
7.Primary Outcome
Title Incidence of Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
Hide Description [Not Specified]
Time Frame From the first dose of study treatment until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 Part 2
Hide Arm/Group Description:
Subjects with relapsed orrefractory malignantmesothelioma regardless ofBAP1 status were to be treatedand PK blood samplescollected after a singletazemetostat 800 mg dose onCycle 1 Day 1 and afterrepeated twice daily doses oftazemetostat 800 mg on Cycle1 Day 15. Subjects were toreceive a single oral 800 mgtazemetostat dose on Cycle 1Day 1. Starting on Cycle 1 Day2, tazemetostat was orallyadministered at a dose of 800mg twice daily.
Subjects with BAP1-deficientrelapsed or refractorymalignant mesothelioma wereto receive orally administeredtazemetostat 800 mg twicedaily starting on Cycle 1 Day1
Overall Number of Participants Analyzed 13 61
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
13
 100.0%
60
  98.4%
Any TEAE Grade 3 or 4
5
  38.5%
31
  50.8%
Any Treatment-Related TEAE
8
  61.5%
44
  72.1%
Any Treatment-Related TEAE Grade 3 or 4
3
  23.1%
9
  14.8%
Any TEAE Leading to Dose Reduction or 4or() {
0
   0.0%
3
   4.9%
Any TEAE Leading to Study Drug Interruption��
5
  38.5%
22
  36.1%
Any TEAE Leading to Study Drug Discontinuation
0
   0.0%
2
   3.3%
Any TESAENR
2
  15.4%
23
  37.7%
Any Treatment-Related TESAE
1
   7.7%
2
   3.3%
Any Protocol Defined AE of Special Interestion
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Part 1 and 2: Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR])
Hide Description ORR (confirmed CR+PR) to tazemetostat in subjects with relapsed/refractory malignant mesothelioma using disease-appropriate standardized response criteria (modified RECIST or RECIST 1.1)
Time Frame Assessed every 6 weeks for duration of study participation which is estimated to be 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 Part 2
Hide Arm/Group Description:
Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status
Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
Overall Number of Participants Analyzed 13 61
Measure Type: Count of Participants
Unit of Measure: Participants
Objective Response Rate,
0
   0.0%
2
   3.3%
Complete response
0
   0.0%
0
   0.0%
Partial response
0
   0.0%
2
   3.3%
9.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-Free Survival is defined as the interval of time between the date of the first dose of study drug and the earliest date of disease progression or death due to any cause. PFS was analyzed and listed for the ITT population. PFS was calculated using the Kaplan-Meier method.
Time Frame The patients were assessed for PFS for up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 Part 2
Hide Arm/Group Description:

Part 1 - Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status

Part 2: Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma

Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
Overall Number of Participants Analyzed 13 61
Median (Inter-Quartile Range)
Unit of Measure: Weeks
12
(5.4 to 34.1)
18
(1.6 to 114.3)
10.Secondary Outcome
Title Part 1 and 2: Overall Survival (OS)
Hide Description

OS was analyzed and listed for the ITT population. Subjects who have not died were censored at the date of last contact which was identified from a visit date, study assessment (physical examination, vital signs, ECOG performance status, electrocardiogram [ECG], study drug record, radiological evaluation), AE, medication, or disposition information.

OS was calculated using the Kaplan-Meier method. OS at 12 and 24 weeks along with the associated 2-sided 95% CIs were provided. Median OS, first and third quartiles and associated 95% 2-sided CIs were provided.

Time Frame The patients were assessed for PFS for up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 Part 2
Hide Arm/Group Description:
Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status
Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
Overall Number of Participants Analyzed 13 61
Median (Inter-Quartile Range)
Unit of Measure: Weeks
29.0
(16.3 to 139.7)
41.0
(1.6 to 120.9)
11.Secondary Outcome
Title Part 1 and 2: To Evaluate the Duration of Response (DOR) in Subjects With Confirmed CR or PR
Hide Description

DOR was calculated for subjects with a confirmed CR or PR. DOR is defined as the time from the date of the initial response (CR/PR) to the date of first documented PD or death due to any cause, whichever occurs first.

DOR censoring rules followed those of the PFS analysis defined in the SAP. DOR was analyzed using the Kaplan-Meier methods and the median DOR, first quartile, and third quartile was presented. The associated 2- sided 95% CIs was estimated.

Time Frame Every 6 weeks up to disease progression or start of new anti-cancer therapy assessed for up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part 1 Part 2
Hide Arm/Group Description:
Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 statu
Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
Overall Number of Participants Analyzed 13 61
Measure Type: Count of Participants
Unit of Measure: Participants
DOR great than 6 weeks
0
   0.0%
0
   0.0%
DOR great than 12 weeks
0
   0.0%
0
   0.0%
DOR great than 18 weeks
0
   0.0%
2
   3.3%
12.Secondary Outcome
Title Part 1: To Assess Disease Control Rate (DCR) Defined as Number of Subjects With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Hide Description Overall, the disease control rate (DCR) (calculated as subjects with CR + subjects with PR + subjects with SD at 12 weeks in duration), and the DCR at 24 weeks.
Time Frame The patients were assessed for DCR for up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part
Hide Arm/Group Description:
Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
DCR at 12 weeks
5
  38.5%
DCR at 24 weeks
1
   7.7%
Time Frame Adverse Events were collected over a period of 2 years.
Adverse Event Reporting Description No other adverse events are listed in the CSR.
 
Arm/Group Title Part 1 (Pharmacokinetics) Part 2 (Efficacy)
Hide Arm/Group Description Assessed the pharmacokinetic (PK) and safety profile of single (Cycle 1 day 1) and repeated doses (Cycle 1 day 2 onwards) of 800 mg tazemetostat administered as 400 mg tablets in subjects with relapsed or refractory malignant mesothelioma regardless of BRCA1 associated protein 1 (BAP1) status. To assess disease control rate (DCR) at 12 weeks (consisting of complete response [CR], partial response [PR], or stable disease [SD]) according to modified RECIST (Nowak, 2005) for thoracic disease or RECIST 1.1 elsewhere in subjects with relapsed or refractory BAP1-deficient malignant mesothelioma treated with tazemetostat
All-Cause Mortality
Part 1 (Pharmacokinetics) Part 2 (Efficacy)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/13 (7.69%)      7/61 (11.48%)    
Hide Serious Adverse Events
Part 1 (Pharmacokinetics) Part 2 (Efficacy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      4/61 (6.56%)    
Cardiac disorders     
Pericardial Effusion  1  0/13 (0.00%)  0 2/61 (3.28%)  2
Gastrointestinal disorders     
Abdominal pain  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Ascites  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Incarcerated umbilical hernia  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Intestinal perforation  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Nausea  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Pneumoperitoneum  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Vomiting  1  0/13 (0.00%)  0 1/61 (1.64%)  1
General disorders     
General physical health deterioration  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Infections and infestations     
Liver abscess  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Peritonitis  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Pneumonia  1  0/13 (0.00%)  0 2/61 (3.28%)  2
Sepsis  1  0/13 (0.00%)  0 3/61 (4.92%)  3
Systemic infection  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Investigations     
Electrocardiogram ST segment elevation  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Electrocardiogram T wave inversiontion  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Oxygen saturation decreased  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Hyperglycaemia  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Hyponatraemia  1  0/13 (0.00%)  0 2/61 (3.28%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer Pain  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Malignant ascites  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Squamous cell carcinoma of skin  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Nervous system disorders     
Syncope  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Renal and urinary disorders     
Renal failure  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  2/13 (15.38%)  2 1/61 (1.64%)  1
Dyspnoea  1  1/13 (7.69%)  1 2/61 (3.28%)  2
Vascular disorders     
Embolism  1  1/13 (7.69%)  1 1/61 (1.64%)  1
Air embolism  1  0/13 (0.00%)  0 1/61 (1.64%)  1
Deep vein thrombosis  1  0/13 (0.00%)  0 1/61 (1.64%)  1
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1 (Pharmacokinetics) Part 2 (Efficacy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      59/61 (96.72%)    
Blood and lymphatic system disorders     
Anaemia  1  0/13 (0.00%)  0 13/61 (21.31%)  17
Gastrointestinal disorders     
Nausea  1  6/13 (46.15%)  6 15/61 (24.59%)  22
Vomiting  1  2/13 (15.38%)  4 15/61 (24.59%)  18
Abdominal Distension  1  2/13 (15.38%)  2 5/61 (8.20%)  8
Constipation  1  0/13 (0.00%)  0 7/61 (11.48%)  7
Abdominal pain  1  1/13 (7.69%)  1 4/61 (6.56%)  5
Dyspepsia  1  1/13 (7.69%)  1 2/61 (3.28%)  2
Gastrooesophageal Reflux Disease  1  1/13 (7.69%)  1 1/61 (1.64%)  1
Ascites  1  1/13 (7.69%)  2 0/61 (0.00%)  0
Dysphagia  1  1/13 (7.69%)  1 0/61 (0.00%)  0
Haemorrhoids  1  1/13 (7.69%)  1 0/61 (0.00%)  0
General disorders     
Fatigue  1  4/13 (30.77%)  4 22/61 (36.07%)  28
Asthenia  1  1/13 (7.69%)  1 8/61 (13.11%)  10
Oedema peripheral  1  1/13 (7.69%)  1 6/61 (9.84%)  8
Pyrexia  1  1/13 (7.69%)  1 2/61 (3.28%)  3
Chills  1  1/13 (7.69%)  1 0/61 (0.00%)  0
Infections and infestations     
Throat Irritation  1  1/13 (7.69%)  1 0/61 (0.00%)  0
Lower respiratory tract infection  1  0/13 (0.00%)  0 8/61 (13.11%)  11
Upper respiratory Tract Infection  1  1/13 (7.69%)  1 5/61 (8.20%)  5
Oral candidiasis  1  1/13 (7.69%)  1 3/61 (4.92%)  3
Urinary tract infection  1  0/13 (0.00%)  0 4/61 (6.56%)  4
Injury, poisoning and procedural complications     
Procedural pain  1  1/13 (7.69%)  2 1/61 (1.64%)  1
Investigations     
Weight decreased  1  0/13 (0.00%)  0 12/61 (19.67%)  15
Lymphocyte count decreased  1  2/13 (15.38%)  3 0/61 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  2/13 (15.38%)  3 22/61 (36.07%)  27
Hyperglycaemia  1  1/13 (7.69%)  1 3/61 (4.92%)  3
Hypophosphataemia  1  1/13 (7.69%)  1 1/61 (1.64%)  1
Hypokalaemia  1  1/13 (7.69%)  1 0/61 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  3/13 (23.08%)  3 4/61 (6.56%)  5
Muscle spasms  1  0/13 (0.00%)  0 6/61 (9.84%)  8
Arthralgia  1  1/13 (7.69%)  2 1/61 (1.64%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  3/13 (23.08%)  3 18/61 (29.51%)  33
Nervous system disorders     
Dysgeusia  1  0/13 (0.00%)  0 8/61 (13.11%)  11
Dizziness  1  0/13 (0.00%)  0 4/61 (6.56%)  5
Neuralgia  1  1/13 (7.69%)  1 0/61 (0.00%)  0
Psychiatric disorders     
Insomnia  1  1/13 (7.69%)  1 1/61 (1.64%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  7/13 (53.85%)  13 14/61 (22.95%)  19
Cough  1  2/13 (15.38%)  2 17/61 (27.87%)  17
Dysphonia  1  2/13 (15.38%)  2 3/61 (4.92%)  3
Pleural Effusion  1  1/13 (7.69%)  2 2/61 (3.28%)  2
Epistaxis  1  1/13 (7.69%)  1 0/61 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin  1  1/13 (7.69%)  1 3/61 (4.92%)  3
Dermal cyst  1  1/13 (7.69%)  1 2/61 (3.28%)  2
Night sweats  1  1/13 (7.69%)  1 2/61 (3.28%)  2
Rash  1  1/13 (7.69%)  1 2/61 (3.28%)  3
Dermatitis acneiform  1  1/13 (7.69%)  1 1/61 (1.64%)  1
1
Term from vocabulary, MedDRA (18.1)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kemly Calixte
Organization: Epizyme
Phone: 617-500-0608
EMail: kcalixte@epizyme.com
Layout table for additonal information
Responsible Party: Epizyme, Inc.
ClinicalTrials.gov Identifier: NCT02860286    
Other Study ID Numbers: EZH-203
First Submitted: July 27, 2016
First Posted: August 9, 2016
Results First Submitted: November 16, 2020
Results First Posted: April 9, 2021
Last Update Posted: April 9, 2021