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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 InstituteBoston, Massachusetts  02115
Ocala Oncology CenterOcala, Florida  34474
City of HopeDuarte, California  91010
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Cancer Care NorthwestSpokane, Washington  99202
New York Oncology Hematology, P.C.Albany, New York  12208
Puget Sound Cancer CentersEdmonds, Washington  98026
Texas Oncology - Central Austin Cancer CenterAustin, Texas  78731
Northwest Cancer Specialists, P.C.Portland, Oregon  97227
Rocky Mountain Cancer Centers - AuroraAurora, Colorado  80012
University Hospitals Case Medical CenterCleveland, Ohio  44106
Saint Francis HospitalGreenville, South Carolina  29601
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
Yakima Valley Memorial Hospital / North Star LodgeYakima, Washington  98902
MD Anderson Cancer Center / University of TexasHouston, Texas  77030-4003
Virginia Cancer Specialists, PCFairfax, Virginia  22031
Texas Oncology - BedfordBedford, Texas  76022
Texas Oncology - WacoWaco, Texas  76712
Texas Oncology - Medical City DallasDallas, Texas  
Texas Oncology - Fort Worth 12th AvenueFort Worth, Texas  76104
Minnesota Oncology Hematology P.A.Minneapolis, Minnesota  55404
Willamette Valley Cancer and Research / USOREugene, Oregon  97401
PMK Medical Group Inc., DBA Ventura County Hematology Oncology SpecialistsOxnard, California  93030
Texas Oncology - Dallas PresbyterianDallas, Texas  75231
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer CareChristianburg, Virginia  24073
MD Anderson Cancer Center /The University of TexasHouston, Texas  77030
Texas Oncology Denton SouthDenton, Texas  76210