A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma

December 17, 2014 updated by: Seagen Inc.

A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or Metastatic Renal Cell Carcinoma

This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

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
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center
      • Los Angeles, California, United States, 90095-1678
        • UCLA Medical Center / University of California at Los Angeles
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute / Wayne State University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center / University of Texas
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance / University of Washington

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:

  • Pathologically-confirmed diagnosis of NHL or RCC
  • Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
  • Confirmed CD70 expression
  • Measurable disease, defined as at least 1 lesion >1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion > or equal to 10 mm in diameter for patients with RCC

Exclusion Criteria:

  • Previously received an allogeneic transplant
  • History of another primary malignancy that has not been in remission for at least 3 years
  • Prior anti-CD70-directed therapy

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-75
Drug: SGN-75
SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of antitherapeutic antibodies
Time Frame: Through 1 month following last dose
Through 1 month following last dose
Best clinical response
Time Frame: Every 2 months
Every 2 months
Duration of response, progression-free survival
Time Frame: Every 3 months until progression of disease or initiation of new treatment for cancer
Every 3 months until progression of disease or initiation of new treatment for cancer
Blood concentrations of SGN-75 and metabolites
Time Frame: Through 1 month following last dose
Through 1 month following last dose

Collaborators and Investigators

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

Sponsor

Seagen Inc.

Investigators

  • Study Director: Nancy Whiting, PharmD, BCOP, 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

November 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 16, 2009

First Posted (Estimate)

November 18, 2009

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

  • SGN75-001

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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