A Phase I Dose Escalation Study of SGN-35 Alone and in Combination With Gemcitabine for CD30-Positive Malignancies

December 17, 2014 updated by: Seagen Inc.

A Phase I Dose Escalation Study of Weekly SGN-35 Monotherapy and in Combination With Gemcitabine in Patients With Relapsed/Refractory CD30-positive Hematologic Malignancies

This study will examine the safety profile of SGN-35 alone and in combination with gemcitabine. The study will test increasing doses of SGN-35 given weekly to small groups of patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

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, 35294-3300
        • University of Alabama at Birmingham
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University Medical Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Texas
      • Houston, Texas, United States, 77030-4003
        • 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed CD30-positive hematologic malignancy.
  • Patients with HL must have failed systemic chemotherapy.
  • Patients with other CD30-positive malignancies (including ALCL) must be beyond first remission or refractory to front line chemotherapy.
  • Patients must have measurable disease of at least 1.5 cm as documented by radiographic technique.

Exclusion Criteria:

  • Current diagnosis of primary cutaneous ALCL (systemic ALCL eligible).
  • 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: 1
SGN-35 alone or in combination with gemcitabine
Drug: SGN-35
IV; 0.4 up to 1.8 mg/kg weekly 3 out of 4 weeks; minimum of two 28-day cycles
Other Names:
  • brentuximab vedotin
Drug: gemcitabine
IV; 1000 mg/m2 weekly 3 out of 4 weeks
Other Names:
  • Gemzar

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.

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

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

March 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

April 1, 2008

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

  • SG035-0002

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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