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

NCT02706899 | Terminated Phase 1 Results DMC

• 1 other identifier: SGN33A-004
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 34

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).

Conditions

Myelodysplastic Syndrome

Keywords

Antibody-Drug Conjugate CD33 Antigen

Outcome Measures

Primary Outcomes (2)

• Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study

  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.

  Up to 1 year

• Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study

  N/A - End point not assessed

Secondary Outcomes (7)

• 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

• Complete Response Rate (CR)

  N/A - End point not assessed

• Hematologic Improvement (HI) Rate

  N/A - End point not assessed

• Duration of Response (DOR) Rate

  N/A - End point not assessed

• Progression Free Survival (PFS)

  N/A - End point not assessed

Study Arms (2)

33A + azacitidine

EXPERIMENTAL

Vadastuximab talirine plus azacitidine

Drug: vadastuximab talirine; Drug: Azacitidine

Placebo + azacitidine

ACTIVE COMPARATOR

placebo plus azacitidine

Drug: Azacitidine; Drug: Placebo (for 33A)

Interventions

vadastuximab talirine DRUG

Intravenous (IV) push every 4 weeks

Also known as: 33A, SGN-CD33A

33A + azacitidine

Azacitidine DRUG

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

33A + azacitidine; Placebo + azacitidine

Placebo (for 33A) DRUG

Placebo supplied in single-use vials matching 33A, IV push every 4 weeks

Placebo + azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (34)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, United States

Location

University of Colorado Hospital

Denver, Colorado, United States

Location

Cancer Specialisits of North Florida

Fleming Island, Florida, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Georgia Regents University Hospital

Augusta, Georgia, United States

Location

Rush University Medical Center

Chicago, Illinois, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Location

University of Minnesota Medical Center (UMMC)

Minneapolis, Minnesota, United States

Location

Bozeman Deaconess Health Group

Bozeman, Montana, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, United States

Location

The University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, United States

Location

Weill Cornell

Brooklyn, New York, United States

Location

Westchester Medical Center

Hawthorne, New York, 10532, United States

Location

Columbia University Medical Center

New York, New York, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University (CWRU) - University Hospitals Case Medical Center

Cleveland, Ohio, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Providence Portland Research Center

Portland, Oregon, 97213, United States

Location

Oregon Health & Science

Portland, Oregon, 97239, United States

Location

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Location

Texas Oncology - Austin Midtown

Austin, Texas, United States

Location

Baylor University Medical Center

Dallas, Texas, United States

Location

MD Anderson Cancer Center

Houston, Texas, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, United States

Location

Swedish Medical Center

Seattle, Washington, United States

Location

Froedtert & Medical College of Wisconson Clinical Cancer Center

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

vadastuximab talirine; Azacitidine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Seattle Genetics, Inc.

medinfo@seagen.com

855-473-2436

Study Officials

• Phillip Garfin

  Seagen Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 11, 2016
• Study Start: February 1, 2016
• Primary Completion: November 6, 2017
• Study Completion: November 6, 2017
• Last Updated: February 12, 2019
• Results First Posted: December 21, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

US (34)