Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01461538
First received: October 24, 2011
Last updated: June 30, 2014
Last verified: June 2014
  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
Anemia, Refractory, With Excess of Blasts
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:


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 ]
  • Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Through 3 weeks after dosing (1.8 and 2.4 mg/kg arms) ] [ Designated as safety issue: No ]
  • Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Through 1 week after dosing (1.2 mg/kg arm) ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (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: Adcetris; 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: Adcetris; SGN-35
Experimental: Brentuximab vedotin 1.2 mg/kg
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
Drug: brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Other Name: Adcetris; 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 29 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Neil Josephson, MD Seattle Genetics, Inc.
  More Information

No publications provided by Seattle Genetics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Acute Lymphoid Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Solid Tumors
Anemia, Refractory, with Excess of Blasts
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Immunotherapy
Monomethyl Auristatin E

Additional relevant MeSH terms:
Anemia
Anemia, Refractory
Anemia, Refractory, with Excess of Blasts
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014