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Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS

Sponsor
Seagen Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02706899
Collaborator
(none)
19
Enrollment
34
Locations
2
Arms
21.2
Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate-2 or High Risk Myelodysplastic Syndrome (MDS)
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Nov 6, 2017
Actual Study Completion Date :
Nov 6, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 33A + azacitidine

Vadastuximab talirine plus azacitidine

Drug: vadastuximab talirine
Intravenous (IV) push every 4 weeks
Other Names:
  • 33A
  • SGN-CD33A

    • Drug: Azacitidine
    75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks
    Active Comparator: Placebo + azacitidine

    placebo plus azacitidine

    Drug: Azacitidine
    75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks

    Drug: Placebo (for 33A)
    Placebo supplied in single-use vials matching 33A, IV push every 4 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study [Up to 1 year]

      A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.

    2. Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study [N/A - End point not assessed]

    Secondary Outcome Measures

    1. Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities [Up to 1 year]

      As defined by the number of participants with adverse events and laboratory abnormalities. Participants are included only once per row, even if the participant experienced multiple events applicable to the category.

    2. Complete Response Rate (CR) [N/A - End point not assessed]

      Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the CR rate, as defined by the 2006 IWG criteria for MDS.

    3. Hematologic Improvement (HI) Rate [N/A - End point not assessed]

      Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the HI rate, as defined by the 2006 IWG criteria for MDS.

    4. Duration of Response (DOR) Rate [N/A - End point not assessed]

      Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first observation of response (CR, PR, or Marrow CR) to disease progression/relapse or death from any cause, whichever occurs first.

    5. Progression Free Survival (PFS) [N/A - End point not assessed]

      Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.

    6. Rate of Transformation to Acute Myeloid Leukemia (AML) [N/A - End point not assessed]

      Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the rate of transformation to AML after initiation of study therapy.

    7. Overall Survival (OS) [N/A - End point not assessed]

      Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to death due to any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.

    • Previously untreated for Myelodysplastic Syndrome (MDS)

    • Age ≥18 years of age.

    • Eligible for therapy with azacitidine.

    • Life expectancy of at least 12 weeks.

    • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

    • Adequate baseline laboratory parameters.

    Exclusion Criteria:

    • Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).

    • History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.

    • Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).

    • Candidates for allogeneic stem cell transplant at the time of screening.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Banner MD Anderson Cancer Center Gilbert Arizona United States
    2 University of Southern California Los Angeles California United States 90033
    3 Rocky Mountain Cancer Centers, LLP Aurora Colorado United States
    4 Colorado Blood Cancer Institute Denver Colorado United States
    5 University of Colorado Hospital Denver Colorado United States
    6 Cancer Specialisits of North Florida Fleming Island Florida United States
    7 Mayo Clinic Jacksonville Florida United States 32224
    8 Georgia Regents University Hospital Augusta Georgia United States
    9 Rush University Medical Center Chicago Illinois United States
    10 Center for Cancer and Blood Disorders Bethesda Maryland United States
    11 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States
    12 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States
    13 University of Minnesota Medical Center (UMMC) Minneapolis Minnesota United States
    14 Bozeman Deaconess Health Group Bozeman Montana United States
    15 Hackensack University Medical Center Hackensack New Jersey United States
    16 The University of New Mexico Cancer Research and Treatment Center Albuquerque New Mexico United States
    17 Weill Cornell Brooklyn New York United States
    18 Westchester Medical Center Hawthorne New York United States 10532
    19 Columbia University Medical Center New York New York United States
    20 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27514
    21 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
    22 Case Western Reserve University (CWRU) - University Hospitals Case Medical Center Cleveland Ohio United States
    23 Ohio State University Columbus Ohio United States 43210
    24 Providence Portland Research Center Portland Oregon United States 97213
    25 Oregon Health & Science Portland Oregon United States 97239
    26 University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania United States
    27 Medical University of South Carolina Charleston South Carolina United States
    28 Tennessee Oncology, PLLC Nashville Tennessee United States
    29 Texas Oncology - Austin Midtown Austin Texas United States
    30 Baylor University Medical Center Dallas Texas United States
    31 MD Anderson Cancer Center Houston Texas United States
    32 Cancer Care Centers of South Texas San Antonio Texas United States
    33 Swedish Medical Center Seattle Washington United States
    34 Froedtert & Medical College of Wisconson Clinical Cancer Center Milwaukee Wisconsin United States

    Sponsors and Collaborators

    • Seagen Inc.

    Investigators

    • Study Chair: Phillip Garfin, Seagen Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT02706899
    Other Study ID Numbers:
    • SGN33A-004
    First Posted:
    Mar 11, 2016
    Last Update Posted:
    Feb 12, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Seagen Inc.
    Antibody-Drug Conjugate CD33 Antigen
    Additional relevant MeSH terms:
    Preleukemia
    Myelodysplastic Syndromes
    Syndrome
    Azacitidine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Period Title: Overall Study
    STARTED 13 6
    COMPLETED 0 0
    NOT COMPLETED 13 6

    Baseline Characteristics

    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine Total
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Total of all reporting groups
    Overall Participants 13 6 19
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    72
    66
    72
    Sex: Female, Male (Count of Participants)
    Female
    6
    46.2%
    2
    33.3%
    8
    42.1%
    Male
    7
    53.8%
    4
    66.7%
    11
    57.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    13
    100%
    6
    100%
    19
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    23.1%
    1
    16.7%
    4
    21.1%
    White
    10
    76.9%
    5
    83.3%
    15
    78.9%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    13
    100%
    6
    100%
    19
    100%
    Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants)
    Grade 0: Normal activity
    6
    46.2%
    2
    33.3%
    8
    42.1%
    Grade 1: Symptoms but ambulatory
    6
    46.2%
    4
    66.7%
    10
    52.6%
    Grade 2: In bed less than 50% of the time
    1
    7.7%
    0
    0%
    1
    5.3%

    Outcome Measures

    1. Primary Outcome
    Title Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
    Description A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 13 6
    Vadastuximab talirine doses delayed
    2
    0
    Vadastuximab talirine dosed reduced
    4
    1
    Azacitidine doses delayed
    3
    3
    Azacitidine doses reduced
    2
    2
    Azacitidine unplanned dose adjustments
    3
    0
    2. Primary Outcome
    Title Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study
    Description
    Time Frame N/A - End point not assessed

    Outcome Measure Data

    Analysis Population Description
    No patients were assessed for this outcomes as the study did not progress to Phase 2.
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 0 0
    3. Secondary Outcome
    Title Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
    Description As defined by the number of participants with adverse events and laboratory abnormalities. Participants are included only once per row, even if the participant experienced multiple events applicable to the category.
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 13 6
    Treatment-emergent adverse event (TEAE)
    13
    100%
    6
    100%
    Vadatuximab talirine-related TEAE
    9
    69.2%
    6
    100%
    Azacitidine-related TEAE
    13
    100%
    6
    100%
    Serious TEAE
    9
    69.2%
    4
    66.7%
    Vadatuximab talirine-related serious TEAE
    4
    30.8%
    4
    66.7%
    Azacitidine-related serious TEAE
    5
    38.5%
    4
    66.7%
    TEAE of Grades 3-5
    12
    92.3%
    6
    100%
    Vadatuximab talirine-related TEAE of Grades 3-5
    9
    69.2%
    6
    100%
    Azacitidine-related TEAE of Grades 3-5
    10
    76.9%
    6
    100%
    TEAE with outcome of death
    2
    15.4%
    0
    0%
    Dose-limiting toxicity
    2
    15.4%
    0
    0%
    4. Secondary Outcome
    Title Complete Response Rate (CR)
    Description Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the CR rate, as defined by the 2006 IWG criteria for MDS.
    Time Frame N/A - End point not assessed

    Outcome Measure Data

    Analysis Population Description
    No patients were assessed for this outcomes as the study did not progress to Phase 2.
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 0 0
    5. Secondary Outcome
    Title Hematologic Improvement (HI) Rate
    Description Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the HI rate, as defined by the 2006 IWG criteria for MDS.
    Time Frame N/A - End point not assessed

    Outcome Measure Data

    Analysis Population Description
    No patients were assessed for this outcomes as the study did not progress to Phase 2.
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 0 0
    6. Secondary Outcome
    Title Duration of Response (DOR) Rate
    Description Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first observation of response (CR, PR, or Marrow CR) to disease progression/relapse or death from any cause, whichever occurs first.
    Time Frame N/A - End point not assessed

    Outcome Measure Data

    Analysis Population Description
    No patients were assessed for this outcomes as the study did not progress to Phase 2.
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 0 0
    7. Secondary Outcome
    Title Progression Free Survival (PFS)
    Description Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.
    Time Frame N/A - End point not assessed

    Outcome Measure Data

    Analysis Population Description
    No patients were assessed for this outcomes as the study did not progress to Phase 2.
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 0 0
    8. Secondary Outcome
    Title Rate of Transformation to Acute Myeloid Leukemia (AML)
    Description Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the rate of transformation to AML after initiation of study therapy.
    Time Frame N/A - End point not assessed

    Outcome Measure Data

    Analysis Population Description
    No patients were assessed for this outcomes as the study did not progress to Phase 2.
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 0 0
    9. Secondary Outcome
    Title Overall Survival (OS)
    Description Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to death due to any cause.
    Time Frame N/A - End point not assessed

    Outcome Measure Data

    Analysis Population Description
    No patients were assessed for this outcomes as the study did not progress to Phase 2.
    Arm/Group Title 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    Measure Participants 0 0

    Adverse Events

    Time Frame Up to 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 33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Arm/Group Description Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (5mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks Vadastuximab talirine (33A) plus azacitidine Vadastuximab talirine (10mcg/kg) given via intravenous (IV) push every 4 weeks Azacitidine (75 mg/m^2) given intravenously or subcutaneously x 7 days every 4 weeks
    All Cause Mortality
    33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/13 (61.5%) 0/6 (0%)
    Serious Adverse Events
    33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/13 (69.2%) 4/6 (66.7%)
    Blood and lymphatic system disorders
    Febrile neutropenia 4/13 (30.8%) 4/6 (66.7%)
    Pancytopenia 1/13 (7.7%) 0/6 (0%)
    Gastrointestinal disorders
    Nausea 1/13 (7.7%) 0/6 (0%)
    Vomiting 1/13 (7.7%) 0/6 (0%)
    Infections and infestations
    Pneumonia 2/13 (15.4%) 0/6 (0%)
    Cellulitis 1/13 (7.7%) 0/6 (0%)
    Respiratory syncytial virus infection 1/13 (7.7%) 0/6 (0%)
    Sepsis 1/13 (7.7%) 0/6 (0%)
    Metabolism and nutrition disorders
    Dehydration 1/13 (7.7%) 0/6 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia 1/13 (7.7%) 0/6 (0%)
    Renal and urinary disorders
    Nephrolithiasis 1/13 (7.7%) 0/6 (0%)
    Skin and subcutaneous tissue disorders
    Neutrophilic dermatosis 1/13 (7.7%) 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    33A (5 mcg/kg) + Azacitidine 33A (10 mcg/kg) + Azacitidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/13 (100%) 6/6 (100%)
    Blood and lymphatic system disorders
    Anaemia 6/13 (46.2%) 4/6 (66.7%)
    Thrombocytopenia 5/13 (38.5%) 0/6 (0%)
    Neutropenia 3/13 (23.1%) 0/6 (0%)
    Febrile neutropenia 1/13 (7.7%) 0/6 (0%)
    Leukopenia 1/13 (7.7%) 0/6 (0%)
    Pancytopenia 1/13 (7.7%) 0/6 (0%)
    Cardiac disorders
    Sinus tachycardia 0/13 (0%) 1/6 (16.7%)
    Ear and labyrinth disorders
    Hearing impaired 1/13 (7.7%) 0/6 (0%)
    Eye disorders
    Vision blurred 1/13 (7.7%) 1/6 (16.7%)
    Cataract 1/13 (7.7%) 0/6 (0%)
    Corneal opacity 1/13 (7.7%) 0/6 (0%)
    Photophobia 0/13 (0%) 1/6 (16.7%)
    Gastrointestinal disorders
    Nausea 8/13 (61.5%) 4/6 (66.7%)
    Constipation 6/13 (46.2%) 4/6 (66.7%)
    Diarrhoea 2/13 (15.4%) 3/6 (50%)
    Oral pain 3/13 (23.1%) 1/6 (16.7%)
    Abdominal pain 1/13 (7.7%) 2/6 (33.3%)
    Vomiting 2/13 (15.4%) 1/6 (16.7%)
    Abdominal pain upper 2/13 (15.4%) 0/6 (0%)
    Gastrooesophageal reflux disease 2/13 (15.4%) 0/6 (0%)
    Glossodynia 1/13 (7.7%) 1/6 (16.7%)
    Abdominal pain lower 1/13 (7.7%) 0/6 (0%)
    Anal ulcer 0/13 (0%) 1/6 (16.7%)
    Dry mouth 1/13 (7.7%) 0/6 (0%)
    Dyspepsia 1/13 (7.7%) 0/6 (0%)
    Dysphagia 1/13 (7.7%) 0/6 (0%)
    Hiatus hernia 1/13 (7.7%) 0/6 (0%)
    Proctalgia 0/13 (0%) 1/6 (16.7%)
    General disorders
    Fatigue 6/13 (46.2%) 3/6 (50%)
    Pyrexia 3/13 (23.1%) 2/6 (33.3%)
    Chills 0/13 (0%) 3/6 (50%)
    Asthenia 1/13 (7.7%) 0/6 (0%)
    Catheter site rash 1/13 (7.7%) 0/6 (0%)
    Chest discomfort 1/13 (7.7%) 0/6 (0%)
    Face oedema 0/13 (0%) 1/6 (16.7%)
    Injection site erythema 1/13 (7.7%) 0/6 (0%)
    Injection site rash 1/13 (7.7%) 0/6 (0%)
    Injection site reaction 1/13 (7.7%) 0/6 (0%)
    Localised oedema 1/13 (7.7%) 0/6 (0%)
    Malaise 0/13 (0%) 1/6 (16.7%)
    Oedema peripheral 1/13 (7.7%) 0/6 (0%)
    Peripheral swelling 1/13 (7.7%) 0/6 (0%)
    Infections and infestations
    Pneumonia 3/13 (23.1%) 0/6 (0%)
    Rash pustular 1/13 (7.7%) 2/6 (33.3%)
    Folliculitis 1/13 (7.7%) 1/6 (16.7%)
    Cellulitis 1/13 (7.7%) 0/6 (0%)
    Mucosal infection 0/13 (0%) 1/6 (16.7%)
    Nail infection 0/13 (0%) 1/6 (16.7%)
    Parotitis 1/13 (7.7%) 0/6 (0%)
    Skin candida 1/13 (7.7%) 0/6 (0%)
    Soft tissue infection 0/13 (0%) 1/6 (16.7%)
    Urinary tract infection 0/13 (0%) 1/6 (16.7%)
    Vulvitis 0/13 (0%) 1/6 (16.7%)
    Injury, poisoning and procedural complications
    Contusion 1/13 (7.7%) 1/6 (16.7%)
    Infusion related reaction 1/13 (7.7%) 1/6 (16.7%)
    Fall 0/13 (0%) 1/6 (16.7%)
    Humerus fracture 1/13 (7.7%) 0/6 (0%)
    Investigations
    Neutrophil count decreased 2/13 (15.4%) 3/6 (50%)
    Platelet count decreased 0/13 (0%) 5/6 (83.3%)
    White blood cell count decreased 0/13 (0%) 4/6 (66.7%)
    Blood bilirubin increased 1/13 (7.7%) 2/6 (33.3%)
    Aspartate aminotransferase increased 1/13 (7.7%) 1/6 (16.7%)
    Blood creatinine increased 2/13 (15.4%) 0/6 (0%)
    Alanine aminotransferase increased 0/13 (0%) 1/6 (16.7%)
    Amylase increased 1/13 (7.7%) 0/6 (0%)
    Blood alkaline phosphatase increased 0/13 (0%) 1/6 (16.7%)
    Blood urea increased 1/13 (7.7%) 0/6 (0%)
    Gamma-glutamyltransferase increased 1/13 (7.7%) 0/6 (0%)
    Heart rate irregular 0/13 (0%) 1/6 (16.7%)
    Intraocular pressure increased 1/13 (7.7%) 0/6 (0%)
    Lipase increased 1/13 (7.7%) 0/6 (0%)
    Lymphocyte count decreased 0/13 (0%) 1/6 (16.7%)
    Protein total decreased 1/13 (7.7%) 0/6 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 5/13 (38.5%) 1/6 (16.7%)
    Hypokalaemia 4/13 (30.8%) 1/6 (16.7%)
    Hypocalcaemia 2/13 (15.4%) 1/6 (16.7%)
    Hyponatraemia 2/13 (15.4%) 1/6 (16.7%)
    Hypoalbuminaemia 1/13 (7.7%) 1/6 (16.7%)
    Dehydration 1/13 (7.7%) 0/6 (0%)
    Hypercalcaemia 1/13 (7.7%) 0/6 (0%)
    Hyperglycaemia 0/13 (0%) 1/6 (16.7%)
    Hypermagnesaemia 1/13 (7.7%) 0/6 (0%)
    Hypernatraemia 1/13 (7.7%) 0/6 (0%)
    Hyperuricaemia 1/13 (7.7%) 0/6 (0%)
    Hypomagnesaemia 1/13 (7.7%) 0/6 (0%)
    Hypophosphataemia 0/13 (0%) 1/6 (16.7%)
    Musculoskeletal and connective tissue disorders
    Back pain 2/13 (15.4%) 1/6 (16.7%)
    Arthralgia 1/13 (7.7%) 1/6 (16.7%)
    Neck pain 2/13 (15.4%) 0/6 (0%)
    Pain in extremity 1/13 (7.7%) 1/6 (16.7%)
    Muscular weakness 1/13 (7.7%) 0/6 (0%)
    Musculoskeletal pain 1/13 (7.7%) 0/6 (0%)
    Myalgia 0/13 (0%) 1/6 (16.7%)
    Osteopenia 1/13 (7.7%) 0/6 (0%)
    Nervous system disorders
    Headache 4/13 (30.8%) 3/6 (50%)
    Dizziness 3/13 (23.1%) 3/6 (50%)
    Dysgeusia 2/13 (15.4%) 0/6 (0%)
    Presyncope 0/13 (0%) 2/6 (33.3%)
    Intercranial aneurysm 1/13 (7.7%) 0/6 (0%)
    Peripheral sensory neuropathy 1/13 (7.7%) 0/6 (0%)
    Sinus headache 0/13 (0%) 1/6 (16.7%)
    Syncope 1/13 (7.7%) 0/6 (0%)
    Tremor 0/13 (0%) 1/6 (16.7%)
    Psychiatric disorders
    Insomnia 2/13 (15.4%) 1/6 (16.7%)
    Anxiety 1/13 (7.7%) 0/6 (0%)
    Confusional state 0/13 (0%) 1/6 (16.7%)
    Hallucination 0/13 (0%) 1/6 (16.7%)
    Renal and urinary disorders
    Acute kidney injury 1/13 (7.7%) 0/6 (0%)
    Haematuria 0/13 (0%) 1/6 (16.7%)
    Urinary incontinence 1/13 (7.7%) 0/6 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 4/13 (30.8%) 1/6 (16.7%)
    Epistaxis 3/13 (23.1%) 2/6 (33.3%)
    Cough 3/13 (23.1%) 1/6 (16.7%)
    Oropharyngeal pain 1/13 (7.7%) 3/6 (50%)
    Hiccups 2/13 (15.4%) 0/6 (0%)
    Dysphonia 0/13 (0%) 1/6 (16.7%)
    Hypoxia 1/13 (7.7%) 0/6 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 1/13 (7.7%) 1/6 (16.7%)
    Rash maculo-papular 0/13 (0%) 2/6 (33.3%)
    Decubitus ulcer 1/13 (7.7%) 0/6 (0%)
    Dry skin 0/13 (0%) 1/6 (16.7%)
    Erythema 1/13 (7.7%) 0/6 (0%)
    Hyperhidrosis 0/13 (0%) 1/6 (16.7%)
    Rash 1/13 (7.7%) 0/6 (0%)
    Rash papular 1/13 (7.7%) 0/6 (0%)
    Vascular disorders
    Hypertension 1/13 (7.7%) 0/6 (0%)
    Hypotension 0/13 (0%) 1/6 (16.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Seattle Genetics, Inc.
    Phone 855-473-2436
    Email medinfo@seagen.com
    Responsible Party:
    Seagen Inc.
    ClinicalTrials.gov Identifier:
    NCT02706899
    Other Study ID Numbers:
    • SGN33A-004
    First Posted:
    Mar 11, 2016
    Last Update Posted:
    Feb 12, 2019
    Last Verified:
    Jan 1, 2019