Clinical trial NCT02706899: Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndrome
Keywords: Antibody-Drug Conjugate CD33 Antigen
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
timeFrame: Up to 1 year
measure: Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study
timeFrame: N/A - End point not assessed
Secondary outcomes:
measure: Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities
timeFrame: Up to 1 year
measure: Complete Response Rate (CR)
timeFrame: N/A - End point not assessed
measure: Hematologic Improvement (HI) Rate
timeFrame: N/A - End point not assessed
measure: Duration of Response (DOR) Rate
timeFrame: N/A - End point not assessed
measure: Progression Free Survival (PFS)
timeFrame: N/A - End point not assessed
measure: Rate of Transformation to Acute Myeloid Leukemia (AML)
timeFrame: N/A - End point not assessed
measure: Overall Survival (OS)
timeFrame: N/A - End point not assessed
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Fleming Island
country: United States
facility: Cancer Specialisits of North Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center (UMMC)
state: Minnesota
city: Bozeman
country: United States
facility: Bozeman Deaconess Health Group
state: Montana
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: The University of New Mexico Cancer Research and Treatment Center
state: New Mexico
city: Brooklyn
country: United States
facility: Weill Cornell
state: New York
city: Hawthorne
country: United States
facility: Westchester Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University (CWRU) - University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Providence Portland Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania, Abramson Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Austin Midtown
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconson Clinical Cancer Center
state: Wisconsin
Study officials:
affiliation: Seagen Inc.
name: Phillip Garfin
role: STUDY_CHAIR
References: