Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

December 18, 2014 updated by: Bayer

An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Ontario
      • Sudbury, Ontario, Canada, P3E 5J1
  • France
      • Caen Cedex 5, France, 14076
      • Montpellier Cedex, France, 34298
  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • München, Bayern, Germany, 81675
      • München, Bayern, Germany, 81377
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Münster, Nordrhein-Westfalen, Germany, 48149
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
  • United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 2TL
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
  • United States
    • California
      • La Jolla, California, United States, 92037
    • Indiana
      • Muncie, Indiana, United States, 47304
    • Louisiana
      • New Orleans, Louisiana, United States, 70121-2484
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
      • Greenbelt, Maryland, United States, 20770
    • Michigan
      • Detroit, Michigan, United States, 48201-9027
      • Southfield, Michigan, United States, 48075
    • Missouri
      • St. Louis, Missouri, United States, 63104
      • St. Louis, Missouri, United States, 63110
    • Montana
      • Billings, Montana, United States, 59101
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • Utah
      • Salt Lake City, Utah, United States, 84108
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

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: - measurable disease as defined by the presence of at least one measurable lesion - prior immunotherapy (up to 2 regimens) or prior radiotherapy is permitted but at least 4 weeks must have elapsed prior to enter study - life expectancy of at least 12 weeks - adequate bone marrow, liver and kidney function Exclusion Criteria: - excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, brain metastasis, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.

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: Arm 1
Drug: Bay 59-8862
75 mg/m2 of BAY 59-8862 intravenously over one hour. Treatment will be repeated once every 3 weeks and tumor measurements will be made every 2 cycles till progression, unacceptable toxicity or consent withdrawal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses
Time Frame: At baseline and every 2 cycles during the treatment period
At baseline and every 2 cycles during the treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response
Time Frame: At baseline and every cycle during the treatment period
At baseline and every cycle during the treatment period
Overall survival
Time Frame: Till end of follow up period (up to 2 years)
Till end of follow up period (up to 2 years)
Time to progression
Time Frame: Throughout study
Throughout study
Pharmacokinetics assessment
Time Frame: At cycle 1
At cycle 1
Qualitative and quantitative toxicity profile
Time Frame: Day 1 of each cycle or as clinically indicated
Day 1 of each cycle or as clinically indicated
Physical examinations
Time Frame: As clinically indicated
As clinically indicated
Vital signs data
Time Frame: Throughout study period
Throughout study period
Abnormal laboratory tests
Time Frame: Prior to every cycle till last study visit
Prior to every cycle till last study visit

Collaborators and Investigators

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

Sponsor

Bayer

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

December 1, 2001

Study Completion (Actual)

January 1, 2003

Study Registration Dates

First Submitted

August 30, 2002

First Submitted That Met QC Criteria

September 3, 2002

First Posted (Estimate)

September 4, 2002

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100386

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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