A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma

January 24, 2014 updated by: Seagen Inc.

A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma

This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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
    • California
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers - Midtown
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute / Wayne State University
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital, The
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression
  • Previously treated with at least 1 tyrosine kinase inhibitor (TKI)
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Adequate lung and renal function

Exclusion Criteria:

  • Prior treatment with anti-CD70-directed therapy
  • Received more than one prior treatment with an mTOR inhibitor

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: Arm 1
SGN-75, everolimus
Drug: SGN-75
1-2 mg/kg IV every 21 days
Drug: everolimus
10 mg PO daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Best clinical response according to RECIST Version 1.1
Time Frame: Through 1 month post last dose
Through 1 month post last dose
Progression-free survival
Time Frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival
Time Frame: Until death or study closure, an expected average of 1 year
Until death or study closure, an expected average of 1 year
Blood concentrations of SGN-75 and metabolites
Time Frame: Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose
Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose
Incidence of antitherapeutic antibodies
Time Frame: Pre-dose in most cycles and 1 month post last dose
Pre-dose in most cycles and 1 month post last dose

Collaborators and Investigators

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

Sponsor

Seagen Inc.

Investigators

  • Study Director: Elaina Gartner, MD, Seagen Inc.

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

August 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

September 3, 2012

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN75-002

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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