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Completed

NCT Number: NCT01026233

Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

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.

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Key information

Conditions

Disease, Hodgkin Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital of Cologne, Cologne, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Brentuximab Vedotin

Drug

1.8 mg/kg IV every 21 days

Other names: SGN-35

Primary outcomes

  1. QTc interval

    Time frame: 2-4 days postdose

Secondary outcomes

  1. ECG parameters

    Time frame: 2-4 days postdose

  2. Blood MMAE levels

    Time frame: Through 4 days postdose

  3. Incidence of proarrhythmic adverse events

    Time frame: Through 1 month following last dose

  4. Incidence of adverse events and laboratory abnormalities

    Time frame: Through 1 month following last dose

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Dec 4, 2009
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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