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Trial record 22 of 35 for:    pralatrexate AND cells

KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

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ClinicalTrials.gov Identifier: NCT01626664
Recruitment Status : Completed
First Posted : June 25, 2012
Results First Posted : June 15, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adult T-cell Leukemia-Lymphoma
Interventions Biological: KW-0761
Drug: Pralatrexate
Drug: gemcitabine plus oxaliplatin
Drug: DHAP
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title KW-0761 Investigator's Choice IC Original Then Crossover to KW-0761
Hide Arm/Group Description

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Subjects who were randomized to the Investigator’s Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
Period Title: Randomization Period
Started 47 24 0
Completed 47 24 0
Not Completed 0 0 0
Period Title: Crossover Period
Started 0 0 18
Completed 0 0 18
Not Completed 0 0 0
Arm/Group Title KW-0761 Investigator's Choice Total
Hide Arm/Group Description

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Total of all reporting groups
Overall Number of Baseline Participants 47 24 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 24 participants 71 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
  74.5%
22
  91.7%
57
  80.3%
>=65 years
12
  25.5%
2
   8.3%
14
  19.7%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 47 participants 24 participants 71 participants
55
(22 to 82)
49
(24 to 80)
53
(22 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 24 participants 71 participants
Female
23
  48.9%
14
  58.3%
37
  52.1%
Male
24
  51.1%
10
  41.7%
34
  47.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 24 participants 71 participants
Hispanic or Latino
9
  19.1%
6
  25.0%
15
  21.1%
Not Hispanic or Latino
31
  66.0%
14
  58.3%
45
  63.4%
Unknown or Not Reported
7
  14.9%
4
  16.7%
11
  15.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 47 participants 24 participants 71 participants
White
6
  12.8%
5
  20.8%
11
  15.5%
Asian
2
   4.3%
1
   4.2%
3
   4.2%
Black or African American
32
  68.1%
15
  62.5%
47
  66.2%
Other
1
   2.1%
0
   0.0%
1
   1.4%
Not Applicable
6
  12.8%
3
  12.5%
9
  12.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 24 participants 71 participants
United States 25 14 39
Brazil 3 0 3
United Kingdom 9 4 13
France 6 3 9
Peru 4 3 7
1.Primary Outcome
Title Overall Response Rate
Hide Description

Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = > 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment.

Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment.

Time Frame every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KW-0761 Investigator's Choice
Hide Arm/Group Description:

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Overall Number of Participants Analyzed 47 24
Measure Type: Number
Unit of Measure: participants
Complete Response 2 0
Uncertified Complete Response 0 0
Partial Response 11 2
Stable Disease 0 4
Relapsed Disease or Progressive Disease 16 13
Not Assessable 18 5
Overall Response Rate (Confirmed and Unconfirmed) 13 2
Overall Response Rate Confirmed 5 0
2.Secondary Outcome
Title Progression Free Survival
Hide Description Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared.
Time Frame From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KW-0761 Investigator's Choice
Hide Arm/Group Description:

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Overall Number of Participants Analyzed 47 24
Median (95% Confidence Interval)
Unit of Measure: percentage of subjects
PFS Subjects (%) Alive for at Least: 1 Month
47.5
(31.6 to 61.9)
44.1
(22.8 to 63.4)
PFS Subjects (%) Alive for at Least: 2 Months
29.8
(16.6 to 44.2)
33.0
(14.2 to 53.3)
PFS Subjects (%) Alive for at Least: 3 Months
24.4
(12.4 to 38.5)
26.4
(9.4 to 47.3)
PFS Subjects (%) Alive for at Least: 4 Months
18.3
(7.9 to 32.1)
13.2
(2.4 to 33.5)
PFS Subjects (%) Alive for at Least: 5 Months
18.3
(7.9 to 32.1)
0
(0 to 0)
PFS Subjects (%) Alive for at Least: 6 Months
12.2
(4.0 to 25.1)
0
(0 to 0)
3.Secondary Outcome
Title Overall Survival
Hide Description The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator’s Choice group.
Time Frame up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KW-0761 Investigator's Choice
Hide Arm/Group Description:

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Overall Number of Participants Analyzed 47 24
Median (95% Confidence Interval)
Unit of Measure: percentage of subjects
Subjects (%) Alive for at Least: 1 Month
87.0
(73.2 to 93.9)
91.7
(70.6 to 97.8)
Subjects (%) Alive for at Least: 2 Months
75.6
(60.3 to 85.7)
79.2
(57.0 to 90.8)
Subjects (%) Alive for at Least: 3 Months
59.1
(43.1 to 72.0)
70.8
(48.4 to 84.9)
Subjects (%) Alive for at Least: 4 Months
54.3
(38.5 to 67.7)
66.7
(44.3 to 81.7)
Subjects (%) Alive for at Least: 5 Months
49.5
(33.9 to 63.3)
54.2
(32.7 to 71.4)
Subjects (%) Alive for at Least: 6 Months
44.3
(29.1 to 58.5)
54.2
(32.7 to 71.4)
4.Secondary Outcome
Title Change in Functional Assessment of Cancer Therapy–Lymphoma (FACT-Lym) Total Score
Hide Description The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.
Time Frame From date of randomization until the date of first documented progression, up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in Intention-to-Treat who had both the values at baseline and last observation
Arm/Group Title KW-0761 Investigator's Choice
Hide Arm/Group Description:

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Overall Number of Participants Analyzed 41 24
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 41 participants 21 participants
110.1  (22.15) 106.8  (25.84)
Last Observation Change from Baseline Number Analyzed 27 participants 14 participants
-12.1  (25.60) -14.9  (25.56)
Time Frame From pre-treatment visit until 90 days after the last dose, approximately three months overall
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KW-0761 Investigator's Choice IC Original Then Crossover to KW-0761
Hide Arm/Group Description

anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)

KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression

Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP

Pralatrexate: 30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression

gemcitabine plus oxaliplatin: gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression

DHAP: dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression

Subjects who were randomized to the Investigator’s Choice regimen could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.
All-Cause Mortality
KW-0761 Investigator's Choice IC Original Then Crossover to KW-0761
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/47 (21.28%)      1/24 (4.17%)      12/18 (66.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
KW-0761 Investigator's Choice IC Original Then Crossover to KW-0761
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/47 (55.32%)      10/24 (41.67%)      9/18 (50.00%)    
Blood and lymphatic system disorders       
Anaemia  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Leukocytosis  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Thrombocytopenia  1  0/47 (0.00%)  0 2/24 (8.33%)  2 0/18 (0.00%)  0
Cardiac disorders       
Acute Coronary Syndrome  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Acute Myocardial Infarction  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Atrial Fibrillation  1  2/47 (4.26%)  2 0/24 (0.00%)  0 0/18 (0.00%)  0
Myocarditis  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Gastrointestinal disorders       
Abdominal Distension  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Abdominal Pain  1  1/47 (2.13%)  2 1/24 (4.17%)  1 0/18 (0.00%)  0
Constipation  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Haematemsis  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Ileitis  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Nausea  1  1/47 (2.13%)  1 1/24 (4.17%)  1 0/18 (0.00%)  0
Vomiting  1  2/47 (4.26%)  2 1/24 (4.17%)  1 0/18 (0.00%)  0
General disorders       
Asthenia  1  1/47 (2.13%)  1 0/24 (0.00%)  0 1/18 (5.56%)  1
Disease Progression  1  2/47 (4.26%)  2 0/24 (0.00%)  0 0/18 (0.00%)  0
Fatigue  1  1/47 (2.13%)  1 0/24 (0.00%)  0 1/18 (5.56%)  1
Multi-Organ Failure  1  2/47 (4.26%)  2 0/24 (0.00%)  0 1/18 (5.56%)  1
Pyrexia  1  2/47 (4.26%)  2 0/24 (0.00%)  0 0/18 (0.00%)  0
Immune system disorders       
Anaphylactic Reaction  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Infections and infestations       
Catheter Site Infection  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Cellulitis  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Clostridial Infection  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Cytomegalovirus Infection  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Empyema  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Infective Thrombosis  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Lower Respiratory Tract Infection  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Oropharyngeal Candidiasis  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Pneumocystis Jiroveci Pneumonia  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Pneumonia  1  3/47 (6.38%)  4 0/24 (0.00%)  0 0/18 (0.00%)  0
Post Procedural Sepsis  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Sepsis  1  2/47 (4.26%)  2 0/24 (0.00%)  0 1/18 (5.56%)  1
Septic Shock  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Urosepsis  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Injury, poisoning and procedural complications       
Infusion Related Reaction  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Investigations       
Alanine Aminotransferase Increased  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Amylase Increased  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Aspartate Aminotransferase Increased  1  1/47 (2.13%)  1 1/24 (4.17%)  1 0/18 (0.00%)  0
Bilirubin Conjugated Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Blood Alkaline Phosphatase Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Blood Bilirubin Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Blood Lactate Dehydrogenase Increased  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Lipase Increased  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Urine Ketone Body Present  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Weight Decreased  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Metabolism and nutrition disorders       
Decreased Appetite  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Dehydration  1  0/47 (0.00%)  0 1/24 (4.17%)  1 1/18 (5.56%)  1
Hypercalcaemia  1  7/47 (14.89%)  7 4/24 (16.67%)  4 2/18 (11.11%)  2
Hyperglycaemia  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Hypoglycaemia  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Lactic Acidosis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  2
Tumour Lysis Syndrome  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Flank Pain  1  1/47 (2.13%)  1 1/24 (4.17%)  1 0/18 (0.00%)  0
Mobility Decreased  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Muscular Weakness  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Pain in Extremity  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Central Nervous System Lymphoma  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Nervous system disorders       
Convulsion  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Headache  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Osmotic Demyelination Syndrome  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Peripheral Sensorimotor Neuropathy  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Presyncope  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Tremor  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Psychiatric disorders       
Confusional State  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Renal and urinary disorders       
Renal Failure  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Renal Failure Acute  1  2/47 (4.26%)  2 0/24 (0.00%)  0 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Plerual Effusion  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Pneumothorax  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Pulmonary Toxicity  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Respiratory Failure  1  2/47 (4.26%)  2 0/24 (0.00%)  0 1/18 (5.56%)  1
Skin and subcutaneous tissue disorders       
Dermatitis Acneiform  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Pain of Skin  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Pruritis  1  0/47 (0.00%)  0 1/24 (4.17%)  1 0/18 (0.00%)  0
Skin Hypopigmentation  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
Skin Ulcer  1  1/47 (2.13%)  1 0/24 (0.00%)  0 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
KW-0761 Investigator's Choice IC Original Then Crossover to KW-0761
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/47 (95.74%)      24/24 (100.00%)      17/18 (94.44%)    
Blood and lymphatic system disorders       
Anaemia  1  10/47 (21.28%)  13 3/24 (12.50%)  10 6/18 (33.33%)  11
Leukocytosis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  2
Leukopenia  1  3/47 (6.38%)  3 1/24 (4.17%)  1 0/18 (0.00%)  0
Neutropenia  1  4/47 (8.51%)  10 4/24 (16.67%)  8 2/18 (11.11%)  3
Pancytopenia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Thrombocytopenia  1  6/47 (12.77%)  8 3/24 (12.50%)  5 2/18 (11.11%)  3
Cardiac disorders       
Bradycardia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Tachycardia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  2
Endocrine disorders       
Hypothyroidism  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders       
Abdominal Distension  1  1/47 (2.13%)  1 2/24 (8.33%)  2 2/18 (11.11%)  3
Abdominal Pain  1  7/47 (14.89%)  7 2/24 (8.33%)  2 2/18 (11.11%)  2
Constipation  1  6/47 (12.77%)  7 5/24 (20.83%)  5 1/18 (5.56%)  1
Diarrhoea  1  3/47 (6.38%)  3 7/24 (29.17%)  9 2/18 (11.11%)  2
Diarrhoea Haemorrhagic  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Dry Mouth  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Gastrooesophageal Reflux Disease  1  3/47 (6.38%)  3 1/24 (4.17%)  2 0/18 (0.00%)  0
Haematochezia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Nausea  1  6/47 (12.77%)  7 9/24 (37.50%)  11 0/18 (0.00%)  0
Obstruction Gastric  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Vomiting  1  4/47 (8.51%)  6 7/24 (29.17%)  7 1/18 (5.56%)  1
General disorders       
Asthenia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 3/18 (16.67%)  3
Chest Pain  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Chills  1  0/47 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  2
Fatigue  1  5/47 (10.64%)  8 4/24 (16.67%)  4 1/18 (5.56%)  1
Gait Disturbance  1  0/47 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  2
Malaise  1  0/47 (0.00%)  0 3/24 (12.50%)  3 0/18 (0.00%)  0
Mucosal Inflammation  1  0/47 (0.00%)  0 2/24 (8.33%)  2 0/18 (0.00%)  0
Oedema Peripheral  1  8/47 (17.02%)  8 4/24 (16.67%)  4 3/18 (16.67%)  3
Pain  1  3/47 (6.38%)  3 0/24 (0.00%)  0 1/18 (5.56%)  1
Pyrexia  1  4/47 (8.51%)  4 6/24 (25.00%)  18 3/18 (16.67%)  3
Infections and infestations       
Aspergillosis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Candidiasis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Clostridium Colitis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Folliculitis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Haemophilus Infection  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Lower Respiratory Tract Infection  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Lung Infection  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Oral Candidiasis  1  3/47 (6.38%)  3 1/24 (4.17%)  1 0/18 (0.00%)  0
Pneumonia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Upper Respiratory Tract Infection  1  3/47 (6.38%)  3 0/24 (0.00%)  0 1/18 (5.56%)  1
Urinary Tract Infection  1  2/47 (4.26%)  2 2/24 (8.33%)  2 0/18 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Head Injury  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Infusion Related Reaction  1  21/47 (44.68%)  23 0/24 (0.00%)  0 8/18 (44.44%)  8
Investigations       
Alanine Aminotransferase Increased  1  3/47 (6.38%)  4 2/24 (8.33%)  12 0/18 (0.00%)  0
Amylase Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  2
Aspartate Aminotransferase Increased  1  5/47 (10.64%)  5 2/24 (8.33%)  13 2/18 (11.11%)  2
Bilirubin Conjugated Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  2
Blood Alkaline Phosphatase Increased  1  2/47 (4.26%)  2 3/24 (12.50%)  8 1/18 (5.56%)  1
Blood Bicarbonate Decreased  1  3/47 (6.38%)  3 0/24 (0.00%)  0 0/18 (0.00%)  0
Blood Bilirubin Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 3/18 (16.67%)  3
Blood Creatinine Increased  1  5/47 (10.64%)  5 2/24 (8.33%)  2 1/18 (5.56%)  1
Blood Lactate Dehydrogenase Increased  1  6/47 (12.77%)  7 1/24 (4.17%)  1 1/18 (5.56%)  1
Blood Urea Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Lipase Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  3
Neutrophil Count Decreased  1  2/47 (4.26%)  3 4/24 (16.67%)  4 1/18 (5.56%)  2
Platelet Count Decreased  1  5/47 (10.64%)  5 2/24 (8.33%)  11 0/18 (0.00%)  0
Platelet Count Increased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Transaminases Increased  1  0/47 (0.00%)  0 2/24 (8.33%)  3 0/18 (0.00%)  0
Urine Output Decreased  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Weight Decreased  1  2/47 (4.26%)  2 2/24 (8.33%)  2 0/18 (0.00%)  0
Metabolism and nutrition disorders       
Decreased Appetite  1  4/47 (8.51%)  4 4/24 (16.67%)  4 1/18 (5.56%)  1
Dehydration  1  0/47 (0.00%)  0 0/24 (0.00%)  0 3/18 (16.67%)  3
Diabetes Mellitus  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Hypercalcaemia  1  5/47 (10.64%)  7 4/24 (16.67%)  8 3/18 (16.67%)  3
Hyperglycaemia  1  3/47 (6.38%)  4 0/24 (0.00%)  0 0/18 (0.00%)  0
Hyperkalaemia  1  4/47 (8.51%)  8 1/24 (4.17%)  1 0/18 (0.00%)  0
Hypernatraemia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  3
Hyperuricaemia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Hypoalbuminaemia  1  2/47 (4.26%)  3 2/24 (8.33%)  5 2/18 (11.11%)  5
Hypokalaemia  1  4/47 (8.51%)  4 3/24 (12.50%)  5 3/18 (16.67%)  4
Hypomagnesaemia  1  4/47 (8.51%)  4 3/24 (12.50%)  7 4/18 (22.22%)  5
Hyponatraemia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  2
Hypophosphataemia  1  3/47 (6.38%)  5 3/24 (12.50%)  10 2/18 (11.11%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia  1  3/47 (6.38%)  4 1/24 (4.17%)  1 2/18 (11.11%)  2
Back Pain  1  3/47 (6.38%)  3 1/24 (4.17%)  1 0/18 (0.00%)  0
Bone Pain  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Flank Pain  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Groin Pain  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Muscular Weakness  1  3/47 (6.38%)  4 1/24 (4.17%)  1 2/18 (11.11%)  2
Myalgia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 2/18 (11.11%)  3
Pain in Extremity  1  6/47 (12.77%)  6 0/24 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders       
Dizziness  1  5/47 (10.64%)  6 3/24 (12.50%)  3 1/18 (5.56%)  2
Headache  1  4/47 (8.51%)  4 7/24 (29.17%)  7 0/18 (0.00%)  0
Somnolence  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Psychiatric disorders       
Anxiety  1  0/47 (0.00%)  0 2/24 (8.33%)  2 3/18 (16.67%)  3
Confusional State  1  3/47 (6.38%)  3 0/24 (0.00%)  0 2/18 (11.11%)  2
Hallucination  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Insomnia  1  5/47 (10.64%)  5 2/24 (8.33%)  2 1/18 (5.56%)  1
Renal and urinary disorders       
Proteinuria  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Renal Failure Acute  1  3/47 (6.38%)  3 0/24 (0.00%)  0 1/18 (5.56%)  1
Renail Impairment  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Reproductive system and breast disorders       
Sexual Dysfunction  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders       
Acute Pulmonary Oedema  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Atelectasis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Cough  1  7/47 (14.89%)  7 2/24 (8.33%)  2 1/18 (5.56%)  1
Dyspnoea  1  5/47 (10.64%)  5 3/24 (12.50%)  3 1/18 (5.56%)  1
Epistaxis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Lung Disorder  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Pleural Effusion  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Productive Cough  1  3/47 (6.38%)  3 1/24 (4.17%)  1 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Blood Blister  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Dermatitis Acneiform  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Drug Eruption  1  9/47 (19.15%)  15 0/24 (0.00%)  0 4/18 (22.22%)  6
Dry Skin  1  3/47 (6.38%)  3 0/24 (0.00%)  0 1/18 (5.56%)  1
Ecchymosis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Hyperhydrosis  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Pruritis  1  3/47 (6.38%)  3 0/24 (0.00%)  0 0/18 (0.00%)  0
Rash  1  3/47 (6.38%)  4 0/24 (0.00%)  0 1/18 (5.56%)  1
Vascular disorders       
Deep Vein Thrombosis  1  1/47 (2.13%)  1 2/24 (8.33%)  2 0/18 (0.00%)  0
Flushing  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Hypertension  1  0/47 (0.00%)  0 0/24 (0.00%)  0 1/18 (5.56%)  1
Hypotension  1  4/47 (8.51%)  4 0/24 (0.00%)  0 1/18 (5.56%)  1
1
Term from vocabulary, MedDRA (15.0)
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
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Name/Title: Fiona Herr, Associate Director, Medical Communications
Organization: Kyowa Kirin Inc
Phone: 1 (908) 234-1096
EMail: medinfo-US@kyowakirin.com
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Responsible Party: Kyowa Kirin Pharmaceutical Development, Inc.
ClinicalTrials.gov Identifier: NCT01626664     History of Changes
Other Study ID Numbers: PROTOCOL 0761-009
First Submitted: June 19, 2012
First Posted: June 25, 2012
Results First Submitted: April 2, 2018
Results First Posted: June 15, 2018
Last Update Posted: September 19, 2018