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Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)

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: NCT03552029
Recruitment Status : Terminated (This study was terminated based on a business decision by the Sponsor.)
First Posted : June 11, 2018
Results First Posted : May 20, 2022
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia
Interventions Drug: Quizartinib
Drug: Milademetan
Enrollment 10
Recruitment Details A total of 10 out of the 22 screened participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 8 clinic sites in the United States. Only Part 1 is reported since the study terminated prior to Part 2.
Pre-assignment Details  
Arm/Group Title Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Hide Arm/Group Description Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD. Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
Period Title: Overall Study
Started 4 6
Completed 0 0
Not Completed 4 6
Reason Not Completed
Death             3             0
Adverse Event             1             0
Lack of Efficacy             0             2
Physician Decision             0             1
Study terminated by Sponsor             0             1
Other             0             2
Arm/Group Title Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan Total
Hide Arm/Group Description Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD. Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD. Total of all reporting groups
Overall Number of Baseline Participants 4 6 10
Hide Baseline Analysis Population Description
Demographics and baseline characteristics were assessed in the Enrolled Analysis Set.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 10 participants
64
(51 to 72)
65
(51 to 81)
64
(51 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
Female
0
   0.0%
2
  33.3%
2
  20.0%
Male
4
 100.0%
4
  66.7%
8
  80.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
5
  83.3%
9
  90.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  16.7%
1
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 6 participants 10 participants
4 6 10
1.Primary Outcome
Title Number of Participants With Dose Limiting Toxicities (DLTs) Following Administration of Milademetan in Combination With Quizartinib
Hide Description A dose limiting toxicity (DLT) is defined as any non-hematological treatment-emergent adverse event (TEAE) unless incontrovertibly related to disease progression, intercurrent illness, or concomitant medication, that occurs during the DLT evaluation period (28 days) in each dose level cohort, and is Grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, with exceptions specified: Grade 3 or higher aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels, OR elevation in total bilirubin ≥3.0 × upper limit of normal (ULN) that does not return to ≤Grade 2 elevation within 7 days. Absolute neutrophil count (ANC) <0.5 × 10^9/L, platelets <20 × 10^9/L, and marrow cellularity <5% at 6 weeks or later from start of therapy without any evidence of leukemia.
Time Frame Baseline up to 28 days (Cycle 1) from the start of study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Dose-limiting toxicities were assessed in the DLT Evaluable Set.
Arm/Group Title Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Hide Arm/Group Description:
Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD.
Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
Overall Number of Participants Analyzed 2 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Any Treatment-emergent Adverse Events by System Organ Class Following Administration of Milademetan in Combination With Quizartinib
Hide Description A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) that emerges during the treatment period (from date of first dose up to 35 days after the last dose of the study treatment), having been absent at pretreatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment related to the pretreatment state, when the AE is continuous. AEs collected after 35 days after the last dose of study drug were not considered TEAEs unless they were treatment-related.
Time Frame Baseline up to 35 days after last dose of study drug, up to approximately 2 years 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment-emergent adverse events (irrespective of causality) were assessed in the Safety Analysis Set.
Arm/Group Title Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Hide Arm/Group Description:
Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD.
Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
Overall Number of Participants Analyzed 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAEs
4
 100.0%
6
 100.0%
Any Blood and Lymphatic System Disorders
2
  50.0%
5
  83.3%
Any Cardiac Disorders
1
  25.0%
2
  33.3%
Any Ear and Labyrinth Disorders
1
  25.0%
1
  16.7%
Any Eye Disorders
2
  50.0%
0
   0.0%
Any Gastrointestinal Disorders
4
 100.0%
6
 100.0%
Any General Disorders and Administration Site Conditions
3
  75.0%
5
  83.3%
Any Immune System Disorders
1
  25.0%
0
   0.0%
Any Infections and Infestations
4
 100.0%
1
  16.7%
Any Injury, Poisoning and Procedural Complications
0
   0.0%
3
  50.0%
Any Investigations
3
  75.0%
5
  83.3%
Any Metabolism and Nutrition Disorders
4
 100.0%
5
  83.3%
Any Musculoskeletal and Connective Tissue Disorders
2
  50.0%
4
  66.7%
Any Nervous System Disorders
4
 100.0%
3
  50.0%
Any Psychiatric Disorders
2
  50.0%
2
  33.3%
Any Renal and Urinary Disorders
1
  25.0%
2
  33.3%
Any Respiratory, Thoracic, and Mediastinal Disorders
4
 100.0%
4
  66.7%
Any Skin and Subcutaneous Tissue Disorders
3
  75.0%
5
  83.3%
Any Vascular Disorders
3
  75.0%
1
  16.7%
3.Secondary Outcome
Title Number of Participants With Best Overall Response Following Administration of Milademetan in Combination With Quizartinib
Hide Description Based on European LeukemiaNet criteria, complete remission (CR) was bone marrow (BM) blasts <5%, absence of circulating blasts/blasts with Auer rods, absence of extramedullary disease (EMD), absolute neutrophil count (ANC) ≥1.0×10^9/L, and platelet count ≥100×10^9/L; CR with Incomplete Blood Count Recovery (CRi): all CR criteria except for residual neutropenia or thrombocytopenia; Morphologic Leukemia Free State (MLFS): BM blasts <5%, absence of blasts with Auer rods, absence of EMD, and no hematologic recovery required; Partial Remission (PR): decrease of BM blast percentage by at least 50% (to 5% to 25%) and all criteria of CR; Stable disease: absence of CR, CRi, MLFS, or PR, and criteria for progressive disease (PD) not met; Relapse (after CR/CRi): BM blasts ≥5%, or reappearance of leukemic blasts, or EMD development; and PD: increase in BM blast % and/or increase of absolute blast counts: >50% increase in marrow blasts over baseline, >50% increase in peripheral blasts, or new EMD.
Time Frame Baseline up to first documented response, disease progression, withdrawal, or death (whichever occurs first), up to approximately 2 years 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Best Overall Response was assessed in the Full Analysis Set.
Arm/Group Title Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Hide Arm/Group Description:
Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD.
Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
Overall Number of Participants Analyzed 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
Complete remission (CR)
0
   0.0%
0
   0.0%
Complete Remission with Partial Hematological Recovery (CRh)
0
   0.0%
0
   0.0%
Complete Remission with Incomplete Blood Count Recovery (CRi)
1
  25.0%
3
  50.0%
Morphologic Leukemia Free State (MLFS)
0
   0.0%
0
   0.0%
Partial Remission (PR)
0
   0.0%
0
   0.0%
Stable Disease (SD)
1
  25.0%
2
  33.3%
Relapse
0
   0.0%
0
   0.0%
Missing
2
  50.0%
1
  16.7%
4.Secondary Outcome
Title Overall Response Rate Following Administration of Milademetan in Combination With Quizartinib
Hide Description

Overall response rate was defined as the number of participants with composite Complete Remission (CRc)+Morphological Leukemia Free State (MLFS)+Partial Remission (PR) based on the European LeukemiaNet criteria.

Based on the European LeukemiaNet criteria, CRc was defined as complete remission (CR) as bone marrow (BM) blasts <5%, absence of circulating blasts/blasts with Auer rods, absence of extramedullary disease (EMD), absolute neutrophil count (ANC) ≥1.0×10^9/L, and platelet count ≥100×10^9/L; CR with Incomplete Blood Count Recovery (CRi): all CR criteria except for residual neutropenia or thrombocytopenia; Morphologic Leukemia Free State (MLFS): BM blasts <5%, absence of blasts with Auer rods, absence of EMD, and no hematologic recovery required; Partial Remission (PR): decrease of BM blast percentage by at least 50% (to 5% to 25%) and all criteria of CR.
Time Frame Baseline up to first documented response, disease progression, withdrawal, or death (whichever occurs first), up to approximately 2 years 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Overall response rate was assessed in the Full Analysis Set.
Arm/Group Title Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Hide Arm/Group Description:
Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD.
Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
Overall Number of Participants Analyzed 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
3
  50.0%
Time Frame Treatment-emergent adverse events (TEAEs) were collected from date of first dose up to 35 days after last dose of study drug, up to approximately 2 years 3 months.
Adverse Event Reporting Description A TEAE is defined as an adverse event (AE) that emerges during the treatment period (from date of first dose up to 35 days after the last dose of the study treatment), having been absent at pretreatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity after starting treatment related to the pretreatment state, when the AE is continuous.
 
Arm/Group Title Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Hide Arm/Group Description Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 14 and quizartinib 30 mg QD. Participants with relapsed/refractory FLT3-ITD Mutant AML who received milademetan 90 mg daily (QD) Day 1 - Day 7 and quizartinib 30 mg QD.
All-Cause Mortality
Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Affected / at Risk (%) Affected / at Risk (%)
Total   3/4 (75.00%)   1/6 (16.67%) 
Hide Serious Adverse Events
Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   3/6 (50.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  1/4 (25.00%)  0/6 (0.00%) 
Febrile neutropenia † 1  1/4 (25.00%)  0/6 (0.00%) 
Thrombocytopenia † 1  1/4 (25.00%)  0/6 (0.00%) 
Cardiac disorders     
Bradycardia † 1  1/4 (25.00%)  0/6 (0.00%) 
Gastrointestinal disorders     
Small intestinal obstruction † 1  0/4 (0.00%)  1/6 (16.67%) 
Vomiting † 1  0/4 (0.00%)  1/6 (16.67%) 
General disorders     
Disease progression † 1  0/4 (0.00%)  1/6 (16.67%) 
Infections and infestations     
Arthritis infective † 1  1/4 (25.00%)  0/6 (0.00%) 
Pneumonia † 1  0/4 (0.00%)  1/6 (16.67%) 
Sepsis † 1  1/4 (25.00%)  0/6 (0.00%) 
Septic shock † 1  1/4 (25.00%)  0/6 (0.00%) 
Sinusitis fungal † 1  1/4 (25.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
Subdural haemorrhage † 1  0/4 (0.00%)  1/6 (16.67%) 
Metabolism and nutrition disorders     
Fluid overload † 1  0/4 (0.00%)  1/6 (16.67%) 
Nervous system disorders     
Syncope † 1  0/4 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia † 1  1/4 (25.00%)  1/6 (16.67%) 
Vascular disorders     
Haematoma † 1  1/4 (25.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1, Cohort 1: Quizartinib + Milademetan Part 1, Cohort 1A: Quizartinib + Milademetan
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  1/4 (25.00%)  3/6 (50.00%) 
Febrile neutropenia † 1  2/4 (50.00%)  1/6 (16.67%) 
Neutropenia † 1  1/4 (25.00%)  2/6 (33.33%) 
Thrombocytopenia † 1  1/4 (25.00%)  1/6 (16.67%) 
Cardiac disorders     
Atrial fibrillation † 1  1/4 (25.00%)  0/6 (0.00%) 
Bradycardia † 1  1/4 (25.00%)  0/6 (0.00%) 
Cardiac failure † 1  0/4 (0.00%)  1/6 (16.67%) 
Sinus bradycardia † 1  0/4 (0.00%)  1/6 (16.67%) 
Tachycardia † 1  1/4 (25.00%)  0/6 (0.00%) 
Ear and labyrinth disorders     
Ear pain † 1  1/4 (25.00%)  0/6 (0.00%) 
Hypoacusis † 1  0/4 (0.00%)  1/6 (16.67%) 
Middle ear effusion † 1  1/4 (25.00%)  0/6 (0.00%) 
Eye disorders     
Photophobia † 1  1/4 (25.00%)  0/6 (0.00%) 
Retinal exudates † 1  1/4 (25.00%)  0/6 (0.00%) 
Vision blurred † 1  1/4 (25.00%)  0/6 (0.00%) 
Gastrointestinal disorders     
Abdominal pain † 1  0/4 (0.00%)  1/6 (16.67%) 
Abdominal pain lower † 1  1/4 (25.00%)  0/6 (0.00%) 
Anal incontinence † 1  1/4 (25.00%)  1/6 (16.67%) 
Diarrhoea † 1  2/4 (50.00%)  4/6 (66.67%) 
Dry mouth † 1  0/4 (0.00%)  2/6 (33.33%) 
Dyspepsia † 1  1/4 (25.00%)  1/6 (16.67%) 
Mouth ulceration † 1  0/4 (0.00%)  1/6 (16.67%) 
Nausea † 1  2/4 (50.00%)  4/6 (66.67%) 
Oesophagitis † 1  0/4 (0.00%)  1/6 (16.67%) 
Oral pain † 1  0/4 (0.00%)  1/6 (16.67%) 
Retching † 1  1/4 (25.00%)  0/6 (0.00%) 
Small intestinal obstruction † 1  0/4 (0.00%)  1/6 (16.67%) 
Upper gastrointestinal haemorrhage † 1  1/4 (25.00%)  0/6 (0.00%) 
Vomiting † 1  2/4 (50.00%)  3/6 (50.00%) 
General disorders     
Asthenia † 1  0/4 (0.00%)  1/6 (16.67%) 
Chest discomfort † 1  1/4 (25.00%)  0/6 (0.00%) 
Chills † 1  2/4 (50.00%)  0/6 (0.00%) 
Disease progression † 1  0/4 (0.00%)  1/6 (16.67%) 
Fatigue † 1  1/4 (25.00%)  4/6 (66.67%) 
Generalised oedema † 1  1/4 (25.00%)  0/6 (0.00%) 
Oedema peripheral † 1  1/4 (25.00%)  1/6 (16.67%) 
Pyrexia † 1  2/4 (50.00%)  1/6 (16.67%) 
Swelling face † 1  1/4 (25.00%)  0/6 (0.00%) 
Immune system disorders     
Hypersensitivity † 1  1/4 (25.00%)  0/6 (0.00%) 
Infections and infestations     
Arthritis infective † 1  1/4 (25.00%)  0/6 (0.00%) 
Clostridium difficile colitis † 1  1/4 (25.00%)  0/6 (0.00%) 
Ear infection † 1  1/4 (25.00%)  0/6 (0.00%) 
Oesophageal candidiasis † 1  1/4 (25.00%)  0/6 (0.00%) 
Oral candidiasis † 1  1/4 (25.00%)  0/6 (0.00%) 
Pharyngitis † 1  1/4 (25.00%)  0/6 (0.00%) 
Pneumonia † 1  2/4 (50.00%)  1/6 (16.67%) 
Sepsis † 1  1/4 (25.00%)  0/6 (0.00%) 
Septic shock † 1  1/4 (25.00%)  0/6 (0.00%) 
Sinusitis fungal † 1  1/4 (25.00%)  0/6 (0.00%) 
Upper respiratory tract infection † 1  1/4 (25.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications     
Contusion † 1  0/4 (0.00%)  1/6 (16.67%) 
Fall † 1  0/4 (0.00%)  1/6 (16.67%) 
Ligament sprain † 1  0/4 (0.00%)  1/6 (16.67%) 
Limb injury † 1  0/4 (0.00%)  1/6 (16.67%) 
Procedural pain † 1  0/4 (0.00%)  1/6 (16.67%) 
Subdural haemorrhage † 1  0/4 (0.00%)  1/6 (16.67%) 
Investigations     
Activated partial thromboplastin time prolonged † 1  0/4 (0.00%)  1/6 (16.67%) 
Alanine aminotransferase increased † 1  0/4 (0.00%)  2/6 (33.33%) 
Blood alkaline phosphatase increased † 1  0/4 (0.00%)  1/6 (16.67%) 
Blood creatinine increased † 1  1/4 (25.00%)  2/6 (33.33%) 
Blood fibrinogen decreased † 1  0/4 (0.00%)  1/6 (16.67%) 
C-reactive protein increased † 1  0/4 (0.00%)  2/6 (33.33%) 
Electrocardiogram QT prolonged † 1  0/4 (0.00%)  2/6 (33.33%) 
Fibrin D dimer increased † 1  0/4 (0.00%)  1/6 (16.67%) 
Gamma-glutamyltransferase increased † 1  0/4 (0.00%)  1/6 (16.67%) 
Heart rate decreased † 1  1/4 (25.00%)  0/6 (0.00%) 
Lymphocyte count decreased † 1  0/4 (0.00%)  1/6 (16.67%) 
Neutrophil count decreased † 1  0/4 (0.00%)  1/6 (16.67%) 
Platelet count decreased † 1  0/4 (0.00%)  2/6 (33.33%) 
Urine output decreased † 1  1/4 (25.00%)  0/6 (0.00%) 
White blood cell count decreased † 1  1/4 (25.00%)  2/6 (33.33%) 
Metabolism and nutrition disorders     
Acidosis † 1  1/4 (25.00%)  0/6 (0.00%) 
Decreased appetite † 1  2/4 (50.00%)  4/6 (66.67%) 
Dehydration † 1  0/4 (0.00%)  1/6 (16.67%) 
Fluid overload † 1  1/4 (25.00%)  2/6 (33.33%) 
Hyperglycaemia † 1  0/4 (0.00%)  1/6 (16.67%) 
Hypermagnesaemia † 1  1/4 (25.00%)  0/6 (0.00%) 
Hypernatraemia † 1  1/4 (25.00%)  0/6 (0.00%) 
Hyperphosphataemia † 1  0/4 (0.00%)  1/6 (16.67%) 
Hyperuricaemia † 1  0/4 (0.00%)  1/6 (16.67%) 
Hypervolaemia † 1  1/4 (25.00%)  0/6 (0.00%) 
Hypoalbuminaemia † 1  2/4 (50.00%)  2/6 (33.33%) 
Hypocalcaemia † 1  1/4 (25.00%)  3/6 (50.00%) 
Hypokalaemia † 1  2/4 (50.00%)  4/6 (66.67%) 
Hypomagnesaemia † 1  3/4 (75.00%)  2/6 (33.33%) 
Hyponatraemia † 1  0/4 (0.00%)  2/6 (33.33%) 
Hypophosphataemia † 1  1/4 (25.00%)  2/6 (33.33%) 
Zinc deficiency † 1  0/4 (0.00%)  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  2/4 (50.00%)  1/6 (16.67%) 
Back pain † 1  1/4 (25.00%)  1/6 (16.67%) 
Bone pain † 1  1/4 (25.00%)  1/6 (16.67%) 
Joint swelling † 1  1/4 (25.00%)  0/6 (0.00%) 
Muscular weakness † 1  0/4 (0.00%)  1/6 (16.67%) 
Musculoskeletal pain † 1  1/4 (25.00%)  1/6 (16.67%) 
Myalgia † 1  0/4 (0.00%)  2/6 (33.33%) 
Neck pain † 1  1/4 (25.00%)  1/6 (16.67%) 
Pain in extremity † 1  2/4 (50.00%)  0/6 (0.00%) 
Nervous system disorders     
Balance disorder † 1  0/4 (0.00%)  1/6 (16.67%) 
Dizziness † 1  0/4 (0.00%)  1/6 (16.67%) 
Facial paralysis † 1  0/4 (0.00%)  1/6 (16.67%) 
Headache † 1  1/4 (25.00%)  2/6 (33.33%) 
Hypoaesthesia † 1  2/4 (50.00%)  0/6 (0.00%) 
Lethargy † 1  0/4 (0.00%)  2/6 (33.33%) 
Memory impairment † 1  0/4 (0.00%)  2/6 (33.33%) 
Presyncope † 1  1/4 (25.00%)  0/6 (0.00%) 
Syncope † 1  0/4 (0.00%)  1/6 (16.67%) 
Tremor † 1  0/4 (0.00%)  1/6 (16.67%) 
Psychiatric disorders     
Confusional state † 1  0/4 (0.00%)  1/6 (16.67%) 
Irritability † 1  0/4 (0.00%)  1/6 (16.67%) 
Mental status changes † 1  1/4 (25.00%)  0/6 (0.00%) 
Phonophobia † 1  1/4 (25.00%)  0/6 (0.00%) 
Renal and urinary disorders     
Acute kidney injury † 1  1/4 (25.00%)  1/6 (16.67%) 
Pollakiuria † 1  0/4 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  3/4 (75.00%)  2/6 (33.33%) 
Dysphonia † 1  1/4 (25.00%)  0/6 (0.00%) 
Dyspnoea † 1  2/4 (50.00%)  2/6 (33.33%) 
Epistaxis † 1  1/4 (25.00%)  1/6 (16.67%) 
Hypoxia † 1  1/4 (25.00%)  1/6 (16.67%) 
Nasal congestion † 1  1/4 (25.00%)  1/6 (16.67%) 
Oropharyngeal pain † 1  2/4 (50.00%)  0/6 (0.00%) 
Pleural effusion † 1  0/4 (0.00%)  1/6 (16.67%) 
Pulmonary hypertension † 1  0/4 (0.00%)  1/6 (16.67%) 
Respiratory failure † 1  1/4 (25.00%)  0/6 (0.00%) 
Rhinitis allergic † 1  0/4 (0.00%)  1/6 (16.67%) 
Wheezing † 1  1/4 (25.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer † 1  1/4 (25.00%)  0/6 (0.00%) 
Hyperhidrosis † 1  1/4 (25.00%)  1/6 (16.67%) 
Night sweats † 1  1/4 (25.00%)  1/6 (16.67%) 
Petechiae † 1  0/4 (0.00%)  2/6 (33.33%) 
Pruritus † 1  0/4 (0.00%)  1/6 (16.67%) 
Purpura † 1  0/4 (0.00%)  1/6 (16.67%) 
Rash † 1  0/4 (0.00%)  1/6 (16.67%) 
Rash erythematous † 1  1/4 (25.00%)  0/6 (0.00%) 
Rash maculo-papular † 1  1/4 (25.00%)  1/6 (16.67%) 
Vascular disorders     
Deep vein thrombosis † 1  1/4 (25.00%)  0/6 (0.00%) 
Haematoma † 1  1/4 (25.00%)  0/6 (0.00%) 
Hypertension † 1  0/4 (0.00%)  1/6 (16.67%) 
Hypotension † 1  1/4 (25.00%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
†
Indicates events were collected by systematic assessment
This study was terminated based on a business decision by the Sponsor and was not due to a safety concern.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Contact for Clinical Trial Disclosure Information
Organization: Daiichi Sankyo
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT03552029    
Other Study ID Numbers: DS3032-A-U105
First Submitted: May 17, 2018
First Posted: June 11, 2018
Results First Submitted: December 13, 2021
Results First Posted: May 20, 2022
Last Update Posted: May 20, 2022