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Completed

NCT Number: NCT00430846

Phase I Open-Label Dose Finding Study of SGN-35 for CD30 Positive Hematologic Malignancies

Phase I study to define the safety profile and pharmacokinetic parameters of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies. This is a single-arm, open-label, Phase I dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of SGN-35 in patients with relapsed/refractory CD30-positive hematologic malignancies.

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Key information

Conditions

Lymphoma, Non-Hodgkin Disease, Hodgkin Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic 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 of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have histologically confirmed CD30-positive hematologic malignancy.
  • Patients with HL must have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy after initial radiotherapy for early stage disease and were ineligible for, refused treatment by, or previously received stem cell transplant.
  • Patients must have measurable disease of at least 10mm as documented by radiographic technique.
  • Must be at least 18 years of age.

Exclusion criteria

  • Patients with current diagnosis of pcALCL (systemic ALCL eligible).
  • Patients with history of allogeneic stem cell transplant.
  • Patients who have had previous treatment with any anti-CD30 antibody.

Treatment and study plan

SGN-35

Drug

Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg

Other names: brentuximab vedotin

Primary outcomes

  1. Incidence of adverse events and laboratory abnormalities

    Time frame: 1 month after last dose

Secondary outcomes

  1. PK profile

    Time frame: 2 months after last dose

  2. Immunogenicity (anti-SGN-35 antibodies)

    Time frame: 1 month after last dose

  3. Anti-tumor activity

    Time frame: 1 month after last dose

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

A Phase I Dose Escalation Study of SGN-35 in Patients With Relapsed/Refractory CD30-Positive Hematologic Malignancies.

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 2, 2007
Registry last updated
Dec 18, 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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