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

Primary Purpose

Carcinoma, Renal Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bay 59-8862
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Taxane, Renal Cell Carcinoma, Advanced Renal Cell Carcinoma

Eligibility Criteria

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses

Secondary Outcome Measures

Duration of response
Overall survival
Time to progression
Pharmacokinetics assessment
Qualitative and quantitative toxicity profile
Physical examinations
Vital signs data
Abnormal laboratory tests

Full Information

First Posted
August 30, 2002
Last Updated
December 18, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00044564
Brief Title
Evaluation of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
Official Title
An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell
Keywords
Taxane, Renal Cell Carcinoma, Advanced Renal Cell Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bay 59-8862
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Duration of response
Time Frame
At baseline and every cycle during the treatment period
Title
Overall survival
Time Frame
Till end of follow up period (up to 2 years)
Title
Time to progression
Time Frame
Throughout study
Title
Pharmacokinetics assessment
Time Frame
At cycle 1
Title
Qualitative and quantitative toxicity profile
Time Frame
Day 1 of each cycle or as clinically indicated
Title
Physical examinations
Time Frame
As clinically indicated
Title
Vital signs data
Time Frame
Throughout study period
Title
Abnormal laboratory tests
Time Frame
Prior to every cycle till last study visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121-2484
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-9027
Country
United States
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
City
Caen Cedex 5
ZIP/Postal Code
14076
Country
France
City
Montpellier Cedex
ZIP/Postal Code
34298
Country
France
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
City
Plymouth
State/Province
Devon
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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

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