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

December 17, 2014 updated by: Seagen Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas/MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: SGN-35
Every 21 days. Dose Escalating. 0.1 - 3.6 mg/kg
Other Names:
  • brentuximab vedotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and laboratory abnormalities
Time Frame: 1 month after last dose
1 month after last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
PK profile
Time Frame: 2 months after last dose
2 months after last dose
Immunogenicity (anti-SGN-35 antibodies)
Time Frame: 1 month after last dose
1 month after last dose
Anti-tumor activity
Time Frame: 1 month after last dose
1 month after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Investigators

  • Principal Investigator: Anas Younes, MD, M.D. Anderson Cancer Center
  • Principal Investigator: Andres Forero, MD, University of Alabama at Birmingham
  • Principal Investigator: Nancy Bartlett, MD, Washington University School of Medicine
  • Principal Investigator: John Leonard, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG035-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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