EPO906 Therapy in Patients With Advanced Kidney Cancer

April 16, 2012 updated by: Novartis Pharmaceuticals

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

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

  • France
      • Lyon, France
        • Centre L. Berard
      • Villejuif, France
        • Institut Gustave Roussy
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University Karmanos Cancer Center
    • New York
      • Bronx, New York, United States, 10466
        • Our Lady of Mercy Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Washington
      • Seattle, Washington, United States, 98109
        • 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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The following patients may be eligible for this study:

  • Histologically or cytologically documented evidence of epithelial renal cell carcinoma with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
  • Patients must have had a prior nephrectomy
  • Must have a life expectancy of greater than three (3) months
  • Patients who have had 0-1 prior cytokine treatment regimen (i.e. IL-2, IFN-?) or relapsed less than one year after such treatment may be eligible.

Exclusion Criteria:

The following patients are not eligible for this study:

  • Patients who have received more than one (1) prior cytokine regimen (i.e. IL-2, IFN?) or relapsed more than one year after receiving such treatment are not eligible
  • Patients who have had any prior chemotherapy (including a combination therapy)
  • Patients with symptomatic CNS metastases or leptomeningeal involvement
  • Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  • Patients with severe cardiac insufficiency
  • Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  • History of another malignancy within 3 years prior to study entry except curatively treated non-melanoma skin cancer, prostate cancer, or cervical cancer in situ
  • Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  • HIV+ patients
  • Pregnant or lactating females.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPO906
Drug: epothilone b
EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: every 8 weeks
every 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: every 8 weeks
every 8 weeks
Time to disease progression (TTP)
Time Frame: every 8 weeks
every 8 weeks
Overall Survival (OS)
Time Frame: every 8 weeks
every 8 weeks
Safety and tolerability of EPO906
Time Frame: at each visit
at each visit
Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma
Time Frame: prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment
For biomarker development
prior to the first treatment with EPO906, on the day of any clinically indicated tumor biopsy/resection and on the day of each tumor assessment

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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.

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

April 1, 2002

Primary Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPO906A2207

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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