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EPO906 Therapy in Patients With Advanced Kidney Cancer

Primary Purpose

Kidney Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
epothilone b
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Neoplasms focused on measuring kidney cancer, renal cancer, cancer, tumor, tumour, neoplasm, carcinoma, clear cell, sarcomatoid, papillary, medullary, collecting duct, chromophobe, intravenous, epothilone

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Medical Center
  • University of Maryland
  • Wayne State University Karmanos Cancer Center
  • Our Lady Of Mercy Medical Center
  • Cleveland Clinic Foundation
  • University of Washington
  • Centre L. Berard
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EPO906

Arm Description

Outcomes

Primary Outcome Measures

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Secondary Outcome Measures

Objective response rate (ORR)
Time to disease progression (TTP)
Overall Survival (OS)
Safety and tolerability of EPO906
Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma
For biomarker development

Full Information

First Posted
May 2, 2002
Last Updated
April 16, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00035243
Brief Title
EPO906 Therapy in Patients With Advanced Kidney Cancer
Official Title
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms
Keywords
kidney cancer, renal cancer, cancer, tumor, tumour, neoplasm, carcinoma, clear cell, sarcomatoid, papillary, medullary, collecting duct, chromophobe, intravenous, epothilone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPO906
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
epothilone b
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
every 8 weeks
Title
Time to disease progression (TTP)
Time Frame
every 8 weeks
Title
Overall Survival (OS)
Time Frame
every 8 weeks
Title
Safety and tolerability of EPO906
Time Frame
at each visit
Title
Tumor-specific mutations and gene expression changes in tumor cells with blood cells and plasma
Description
For biomarker development
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Wayne State University Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Our Lady Of Mercy Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Centre L. Berard
City
Lyon
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=608
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

EPO906 Therapy in Patients With Advanced Kidney Cancer

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