Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

NCT01026233 | Completed Phase 1

• 1 other identifier: SGN35-007
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 9

Brief Summary

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

Conditions

Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin

Keywords

Antibodies, Monoclonal; Antibody-Drug Conjugate; Antigens, CD30; Disease, Hodgkin; Drug Therapy; Hematologic Diseases; Immunotherapy; Lymphoma; monomethylauristatin E; Lymphoma, Large-Cell, Anaplastic

Outcome Measures

Primary Outcomes (1)

• QTc interval

  2-4 days postdose

Secondary Outcomes (4)

• ECG parameters

  2-4 days postdose

• Blood MMAE levels

  Through 4 days postdose

• Incidence of proarrhythmic adverse events

  Through 1 month following last dose

• Incidence of adverse events and laboratory abnormalities

  Through 1 month following last dose

Study Arms (1)

1

EXPERIMENTAL

brentuximab vedotin

Drug: brentuximab vedotin

Interventions

brentuximab vedotin DRUG

1.8 mg/kg IV every 21 days

Also known as: SGN-35

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed or refractory CD30-positive malignancy
• Adequate organ function
• ECOG performance status \<2

You may not qualify if:

• Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)
• Current diagnosis of primary cutaneous ALCL
• Acute or chronic graft-versus-host disease
• Prior hematopoietic stem cell transplant within specified timeframe

Sponsors & Collaborators

• Seagen Inc.: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Stanford Cancer Center

Stanford, California, 94305, United States

Location

University of Miami Hospital and Clinics, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Cardinal Bernardin Cancer Center / Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

New York University Cancer Institute

New York, New York, 10016, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University Hospital of Cologne

Cologne, 50924, Germany

Location

Related Publications (3)

• Han TH, Chen R, Advani R, Berryman RB, Smith SE, Forero-Torres A, Rosenblatt JD, Smith MR, Zain J, Hunder NN, Engert A. Brentuximab vedotin does not cause clinically relevant QTc interval prolongation in patients with CD30-positive hematologic malignancies. Cancer Chemother Pharmacol. 2013 Jul;72(1):241-9. doi: 10.1007/s00280-013-2192-z. Epub 2013 May 30.

  PMID: 23719719 RESULT

• Rothe A, Sasse S, Goergen H, Eichenauer DA, Lohri A, Jager U, Bangard C, Boll B, von Bergwelt Baildon M, Theurich S, Borchmann P, Engert A. Brentuximab vedotin for relapsed or refractory CD30+ hematologic malignancies: the German Hodgkin Study Group experience. Blood. 2012 Aug 16;120(7):1470-2. doi: 10.1182/blood-2012-05-430918. Epub 2012 Jul 11.

  PMID: 22786877 DERIVED

• Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.

  PMID: 22510871 DERIVED

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Hematologic Diseases; Lymphoma

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Naomi Hunder, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2011
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

US (8); DE (1)