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A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies


Phase 2
6 Years
N/A
Open (Enrolling)
Both
Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Solid Tumors

Thank you

Trial Information

A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies


Inclusion Criteria:



- Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy

- Have failed, refused, or have been deemed ineligible for standard therapy

- Measurable disease

- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a
Karnofsky or Lansky Performance Status score greater than or equal to 70

Exclusion Criteria:

- Primary diagnosis of lymphoma or central nervous system (CNS) malignancy

- History of another primary invasive malignancy that has not been definitively treated
or in remission for at least 3 years

- Evidence of active cerebral/meningeal disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR)

Outcome Time Frame:

Through 1 month following last dose

Safety Issue:

No

Principal Investigator

Tina Albertson, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-013

NCT ID:

NCT01461538

Start Date:

October 2011

Completion Date:

February 2014

Related Keywords:

  • Acute Lymphoid Leukemia
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Multiple Myeloma
  • Solid Tumors
  • Acute Lymphoid Leukemia
  • Chronic Lymphocytic Leukemia
  • Acute Myeloid Leukemia
  • Multiple Myeloma
  • Solid Tumors
  • Antibodies, Monoclonal
  • Antibody-Drug Conjugate
  • Antigens, CD30
  • Drug Therapy
  • Hematologic Diseases
  • Immunotherapy
  • Monomethyl Auristatin E
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Ocala Oncology Center Ocala, Florida  34474
City of Hope Duarte, California  91010
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Cancer Care Northwest Spokane, Washington  99202
New York Oncology Hematology, P.C. Albany, New York  12208
Puget Sound Cancer Centers Edmonds, Washington  98026
Texas Oncology - Central Austin Cancer Center Austin, Texas  78731
Northwest Cancer Specialists, P.C. Portland, Oregon  97227
Rocky Mountain Cancer Centers - Aurora Aurora, Colorado  80012
University Hospitals Case Medical Center Cleveland, Ohio  44106
Saint Francis Hospital Greenville, South Carolina  29601
Indiana University Simon Cancer Center Indianapolis, Indiana  46202
Yakima Valley Memorial Hospital / North Star Lodge Yakima, Washington  98902
MD Anderson Cancer Center / University of Texas Houston, Texas  77030-4003
Virginia Cancer Specialists, PC Fairfax, Virginia  22031
Texas Oncology - Bedford Bedford, Texas  76022
Texas Oncology - Waco Waco, Texas  76712
Texas Oncology - Medical City Dallas Dallas, Texas  
Texas Oncology - Fort Worth 12th Avenue Fort Worth, Texas  76104
Minnesota Oncology Hematology P.A. Minneapolis, Minnesota  55404
Willamette Valley Cancer and Research / USOR Eugene, Oregon  97401
PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists Oxnard, California  93030
Texas Oncology - Dallas Presbyterian Dallas, Texas  75231
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care Christianburg, Virginia  24073
MD Anderson Cancer Center /The University of Texas Houston, Texas  77030
Texas Oncology Denton South Denton, Texas  76210