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Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study is currently recruiting participants.
Verified May 2013 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01461538
First received: October 24, 2011
Last updated: May 30, 2013
Last verified: May 2013
History of Changes
  Purpose

This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.


Condition Intervention Phase
Acute Lymphoid Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Multiple Myeloma
Solid Tumors
 Drug: brentuximab vedotin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
  • Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, 8, 12, 16, and at the end of treatment assessment: predose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
 Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: SGN-35
Experimental: Brentuximab vedotin 2.4 mg/kg
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
 Drug: brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: SGN-35

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461538

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

  Show 26 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Tina Albertson, MD, PhD Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01461538     History of Changes
Other Study ID Numbers: SGN35-013
Study First Received: October 24, 2011
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013