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A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients

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: NCT02614560
Recruitment Status : Terminated
First Posted : November 25, 2015
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Myeloid Leukemia
Interventions Drug: Fludarabine
Drug: Melphalan
Drug: vadastuximab talirine
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Hide Arm/Group Description

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Post-allo vadastuximab talirine

vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Period Title: Overall Study
Started 6 8
Completed 0 6
Not Completed 6 2
Reason Not Completed
Death             6             2
Arm/Group Title Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant) Total
Hide Arm/Group Description

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Post-allo vadastuximab talirine

vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Total of all reporting groups
Overall Number of Baseline Participants 6 8 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 14 participants
58.0
(50 to 69)
58.0
(25 to 64)
58.0
(25 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
Female
3
  50.0%
3
  37.5%
6
  42.9%
Male
3
  50.0%
5
  62.5%
8
  57.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
Hispanic or Latino
0
   0.0%
1
  12.5%
1
   7.1%
Not Hispanic or Latino
6
 100.0%
7
  87.5%
13
  92.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 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
1
  16.7%
0
   0.0%
1
   7.1%
White
5
  83.3%
8
 100.0%
13
  92.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 8 participants 14 participants
6 8 14
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 14 participants
Grade 0: Normal activity
0
   0.0%
1
  12.5%
1
   7.1%
Grade 1: Symptoms but ambulatory
6
 100.0%
7
  87.5%
13
  92.9%
[1]
Measure Description: 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed less than 50% of the time; 3= In bed more than 50% of the time; 4=100% bedridden; 5=Dead
1.Primary Outcome
Title Incidence of Adverse Events
Hide Description AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.
Time Frame Approximately 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Hide Arm/Group Description:

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Post-allo vadastuximab talirine

vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Overall Number of Participants Analyzed 6 8
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
6
 100.0%
8
 100.0%
AEs Related to Vadatuximab Talirine
6
 100.0%
7
  87.5%
AEs Leading to Treatment Discontinuation
0
   0.0%
1
  12.5%
Grade 3 or Higher TEAEs
6
 100.0%
6
  75.0%
Serious AEs
5
  83.3%
2
  25.0%
2.Primary Outcome
Title Incidence of Laboratory Abnormalities
Hide Description Number (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.
Time Frame Approximately 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Hide Arm/Group Description:

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Post-allo vadastuximab talirine

vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Overall Number of Participants Analyzed 6 8
Measure Type: Count of Participants
Unit of Measure: Participants
Any chemistry test
4
  66.7%
3
  37.5%
Amylase (iu/l)
3
  50.0%
0
   0.0%
Alanine aminotransferase (iu/l)
1
  16.7%
1
  12.5%
Aspartate aminotransferase (iu/l)
1
  16.7%
0
   0.0%
Total bilirubin (mg/dl)
3
  50.0%
0
   0.0%
Uric acid (mg/dl)
1
  16.7%
0
   0.0%
Lipase (iu/l)
0
   0.0%
1
  12.5%
Sodium (meq/l)
0
   0.0%
1
  12.5%
Any hematology test
6
 100.0%
5
  62.5%
Hemoglobin (g/dl)
3
  50.0%
0
   0.0%
Lymphocytes (x10^3/ul)
6
 100.0%
1
  12.5%
Neutrophils (x10^3/ul)
6
 100.0%
4
  50.0%
Platlets (x10^3/ul)
6
 100.0%
4
  50.0%
White blood cell count (x10^3/ul)
6
 100.0%
5
  62.5%
3.Primary Outcome
Title 1-year Survival Rate
Hide Description 1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients set
Arm/Group Title Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Hide Arm/Group Description:

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Post-allo vadastuximab talirine

vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Overall Number of Participants Analyzed 6 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0 [1] 
(NA to NA)
75
(31 to 93)
[1]
Insufficient participants with events to calculate confidence interval.
4.Primary Outcome
Title Rate of MRD Negativity
Hide Description Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients set, pre-allo cohort
Arm/Group Title Pre-allo (Before Stem Cell Transplant)
Hide Arm/Group Description:

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Overall Number of Participants Analyzed 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day -1 Rate of MRD Negativity
NA [1] 
(NA to NA)
Day 30 Rate of MRD Negativity
75
(19.4 to 99.4)
[1]
Insufficient number of participants with events to estimate rate
5.Secondary Outcome
Title Best Response of CR or CRi
Hide Description Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Part A (pre-alloSCT) only
Arm/Group Title Pre-allo (Before Stem Cell Transplant)
Hide Arm/Group Description:

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
6.Secondary Outcome
Title Duration of Response
Hide Description Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause.
Time Frame 9 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Part A (pre-alloSCT) only
Arm/Group Title Pre-allo (Before Stem Cell Transplant)
Hide Arm/Group Description:

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: weeks
6.57
(3 to 9)
7.Secondary Outcome
Title Overall Survival
Hide Description Defined as the time from the day of alloSCT to the date of death due to any cause.
Time Frame Approximately 96 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Hide Arm/Group Description:

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Post-allo vadastuximab talirine

vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

Overall Number of Participants Analyzed 6 8
Median (Full Range)
Unit of Measure: weeks
11.07
(7.43 to 15.71)
NA [1] 
(31.14 to NA)
[1]
<50% of participants experienced an event
Time Frame Up to approximately 1 year
Adverse Event Reporting Description Treatment-emergent adverse events: a newly occurring or worsening adverse event after the first dose of study drug.
 
Arm/Group Title Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Hide Arm/Group Description

Pre-allo reduced intensity chemotherapy vadastuximab talirine (melphalan and fludarabine)

Fludarabine: 30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)

Melphalan: Melphalan 140 mg/m2 intravenously, 2 days before the transplant

vadastuximab talirine: Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant

Post-allo vadastuximab talirine

vadastuximab talirine: Post-allo (after stem cell transplant) given on Day 1 of each cycle

All-Cause Mortality
Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   2/8 (25.00%) 
Hide Serious Adverse Events
Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   2/8 (25.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/6 (16.67%)  0/8 (0.00%) 
General disorders     
Pyrexia  1  1/6 (16.67%)  0/8 (0.00%) 
Hepatobiliary disorders     
Venoocclusive liver disease  1  1/6 (16.67%)  0/8 (0.00%) 
Immune system disorders     
Graft versus host disease in gastrointestinal tract  1  1/6 (16.67%)  0/8 (0.00%) 
Graft versus host disease in lung  1  0/6 (0.00%)  1/8 (12.50%) 
Infections and infestations     
Device related infection  1  1/6 (16.67%)  0/8 (0.00%) 
Parotitis  1  1/6 (16.67%)  0/8 (0.00%) 
Pneumonia  1  0/6 (0.00%)  1/8 (12.50%) 
Sepsis  1  1/6 (16.67%)  0/8 (0.00%) 
Urinary tract infection  1  1/6 (16.67%)  0/8 (0.00%) 
Injury, poisoning and procedural complications     
Transfusion reaction  1  1/6 (16.67%)  0/8 (0.00%) 
Investigations     
Neutrophil count decreased  1  0/6 (0.00%)  1/8 (12.50%) 
Platelet count decreased  1  0/6 (0.00%)  1/8 (12.50%) 
White blood cell count decreased  1  0/6 (0.00%)  1/8 (12.50%) 
Renal and urinary disorders     
Acute kidney injury  1  2/6 (33.33%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Organising pneumonia  1  0/6 (0.00%)  1/8 (12.50%) 
Respiratory failure  1  1/6 (16.67%)  0/8 (0.00%) 
Vascular disorders     
Venoocclusive disease  1  1/6 (16.67%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-allo (Before Stem Cell Transplant) Post-allo (After Stem Cell Transplant)
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/6 (16.67%)  1/8 (12.50%) 
Febrile neutropenia  1  1/6 (16.67%)  0/8 (0.00%) 
Leukopenia  1  0/6 (0.00%)  3/8 (37.50%) 
Neutropenia  1  1/6 (16.67%)  5/8 (62.50%) 
Thrombocytopenia  1  2/6 (33.33%)  5/8 (62.50%) 
Cardiac disorders     
Atrial fibrillation  1  1/6 (16.67%)  0/8 (0.00%) 
Atrial flutter  1  1/6 (16.67%)  0/8 (0.00%) 
Cardiomegaly  1  1/6 (16.67%)  0/8 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  0/6 (0.00%)  1/8 (12.50%) 
Eye disorders     
Conjunctival haemorrhage  1  1/6 (16.67%)  0/8 (0.00%) 
Dry eye  1  0/6 (0.00%)  1/8 (12.50%) 
Eye discharge  1  0/6 (0.00%)  1/8 (12.50%) 
Eye pain  1  0/6 (0.00%)  1/8 (12.50%) 
Eye pruritus  1  1/6 (16.67%)  0/8 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/6 (16.67%)  0/8 (0.00%) 
Abdominal pain  1  2/6 (33.33%)  0/8 (0.00%) 
Ascites  1  1/6 (16.67%)  0/8 (0.00%) 
Constipation  1  1/6 (16.67%)  2/8 (25.00%) 
Diarrhoea  1  3/6 (50.00%)  1/8 (12.50%) 
Dry mouth  1  1/6 (16.67%)  0/8 (0.00%) 
Enterocolitis  1  1/6 (16.67%)  0/8 (0.00%) 
Flatulence  1  1/6 (16.67%)  0/8 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/6 (16.67%)  0/8 (0.00%) 
Nausea  1  5/6 (83.33%)  2/8 (25.00%) 
Proctalgia  1  0/6 (0.00%)  1/8 (12.50%) 
Stomatitis  1  3/6 (50.00%)  0/8 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/6 (16.67%)  0/8 (0.00%) 
Vomiting  1  4/6 (66.67%)  2/8 (25.00%) 
General disorders     
Asthenia  1  0/6 (0.00%)  1/8 (12.50%) 
Chills  1  2/6 (33.33%)  0/8 (0.00%) 
Face oedema  1  1/6 (16.67%)  1/8 (12.50%) 
Fatigue  1  3/6 (50.00%)  4/8 (50.00%) 
Malaise  1  1/6 (16.67%)  0/8 (0.00%) 
Non-cardiac chest pain  1  3/6 (50.00%)  0/8 (0.00%) 
Oedema peripheral  1  5/6 (83.33%)  1/8 (12.50%) 
Pyrexia  1  1/6 (16.67%)  1/8 (12.50%) 
Immune system disorders     
Graft versus host disease in eye  1  0/6 (0.00%)  1/8 (12.50%) 
Infections and infestations     
Candida infection  1  1/6 (16.67%)  1/8 (12.50%) 
Device related infection  1  1/6 (16.67%)  0/8 (0.00%) 
Enterococcal infection  1  1/6 (16.67%)  0/8 (0.00%) 
Pneumonia fungal  1  1/6 (16.67%)  0/8 (0.00%) 
Systemic candida  1  1/6 (16.67%)  0/8 (0.00%) 
Upper respiratory tract infection  1  0/6 (0.00%)  1/8 (12.50%) 
Injury, poisoning and procedural complications     
Contusion  1  0/6 (0.00%)  1/8 (12.50%) 
Fall  1  1/6 (16.67%)  0/8 (0.00%) 
Investigations     
Blood alkaline phosphatase increased  1  0/6 (0.00%)  1/8 (12.50%) 
Blood creatinine increased  1  0/6 (0.00%)  1/8 (12.50%) 
Respirovirus test positive  1  0/6 (0.00%)  1/8 (12.50%) 
Staphylococcus test positive  1  1/6 (16.67%)  0/8 (0.00%) 
Weight decreased  1  0/6 (0.00%)  1/8 (12.50%) 
Weight increased  1  1/6 (16.67%)  0/8 (0.00%) 
White blood cell count decreased  1  0/6 (0.00%)  1/8 (12.50%) 
Metabolism and nutrition disorders     
Decreased appetite  1  3/6 (50.00%)  0/8 (0.00%) 
Dehydration  1  0/6 (0.00%)  1/8 (12.50%) 
Hyperglycaemia  1  3/6 (50.00%)  0/8 (0.00%) 
Hypokalaemia  1  0/6 (0.00%)  2/8 (25.00%) 
Hyponatraemia  1  1/6 (16.67%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/6 (0.00%)  2/8 (25.00%) 
Arthritis  1  0/6 (0.00%)  1/8 (12.50%) 
Back pain  1  2/6 (33.33%)  1/8 (12.50%) 
Bone pain  1  1/6 (16.67%)  2/8 (25.00%) 
Joint swelling  1  0/6 (0.00%)  1/8 (12.50%) 
Neck pain  1  1/6 (16.67%)  0/8 (0.00%) 
Pain in extremity  1  0/6 (0.00%)  1/8 (12.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/6 (0.00%)  1/8 (12.50%) 
Nervous system disorders     
Dysgeusia  1  1/6 (16.67%)  0/8 (0.00%) 
Headache  1  3/6 (50.00%)  3/8 (37.50%) 
Memory impairment  1  1/6 (16.67%)  0/8 (0.00%) 
Peripheral sensory neuropathy  1  1/6 (16.67%)  0/8 (0.00%) 
Seizure  1  1/6 (16.67%)  0/8 (0.00%) 
Somnolence  1  1/6 (16.67%)  0/8 (0.00%) 
Tremor  1  1/6 (16.67%)  0/8 (0.00%) 
Psychiatric disorders     
Agitation  1  1/6 (16.67%)  0/8 (0.00%) 
Confusional state  1  1/6 (16.67%)  0/8 (0.00%) 
Depression  1  1/6 (16.67%)  0/8 (0.00%) 
Hallucination  1  1/6 (16.67%)  0/8 (0.00%) 
Insomnia  1  5/6 (83.33%)  0/8 (0.00%) 
Mental status changes  1  1/6 (16.67%)  0/8 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/6 (16.67%)  1/8 (12.50%) 
Bladder hypertrophy  1  1/6 (16.67%)  0/8 (0.00%) 
Haematuria  1  1/6 (16.67%)  0/8 (0.00%) 
Pollakiuria  1  1/6 (16.67%)  1/8 (12.50%) 
Renal failure  1  1/6 (16.67%)  0/8 (0.00%) 
Urinary incontinence  1  1/6 (16.67%)  0/8 (0.00%) 
Urinary retention  1  1/6 (16.67%)  0/8 (0.00%) 
Urinary tract pain  1  1/6 (16.67%)  0/8 (0.00%) 
Reproductive system and breast disorders     
Menorrhagia  1  1/6 (16.67%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/6 (33.33%)  0/8 (0.00%) 
Dysphonia  1  1/6 (16.67%)  0/8 (0.00%) 
Dyspnoea  1  4/6 (66.67%)  0/8 (0.00%) 
Epistaxis  1  3/6 (50.00%)  1/8 (12.50%) 
Hiccups  1  1/6 (16.67%)  0/8 (0.00%) 
Hypoxia  1  1/6 (16.67%)  0/8 (0.00%) 
Nasal congestion  1  1/6 (16.67%)  1/8 (12.50%) 
Oropharyngeal pain  1  1/6 (16.67%)  0/8 (0.00%) 
Pleural effusion  1  1/6 (16.67%)  0/8 (0.00%) 
Productive cough  1  0/6 (0.00%)  1/8 (12.50%) 
Pulmonary artery wall hypertrophy  1  1/6 (16.67%)  0/8 (0.00%) 
Pulmonary mass  1  1/6 (16.67%)  0/8 (0.00%) 
Pulmonary oedema  1  1/6 (16.67%)  0/8 (0.00%) 
Pulmonary pain  1  1/6 (16.67%)  0/8 (0.00%) 
Tachypnoea  1  1/6 (16.67%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  1/6 (16.67%)  0/8 (0.00%) 
Dry skin  1  0/6 (0.00%)  2/8 (25.00%) 
Erythema  1  0/6 (0.00%)  1/8 (12.50%) 
Pruritus  1  0/6 (0.00%)  1/8 (12.50%) 
Rash maculo-papular  1  2/6 (33.33%)  1/8 (12.50%) 
Skin lesion  1  1/6 (16.67%)  0/8 (0.00%) 
Vascular disorders     
Embolism  1  0/6 (0.00%)  1/8 (12.50%) 
Hypertension  1  1/6 (16.67%)  1/8 (12.50%) 
Hypotension  1  1/6 (16.67%)  0/8 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
No patients were enrolled in Phase 2 due to study termination.
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: Chief Medical Officer
Organization: Seattle Genetics, Inc.
Phone: 855-473-2436
EMail: medinfo@seagen.com
Layout table for additonal information
Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT02614560    
Other Study ID Numbers: SGN33A-003
First Submitted: November 20, 2015
First Posted: November 25, 2015
Results First Submitted: September 5, 2018
Results First Posted: January 9, 2019
Last Update Posted: January 9, 2019