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

NCT ID: NCT00044564

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2003-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Renal Cell

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Taxane Renal Cell Carcinoma Advanced Renal Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type EXPERIMENTAL

Bay 59-8862

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

La Jolla, California, United States

Site Status

Muncie, Indiana, United States

Site Status

New Orleans, Louisiana, United States

Site Status

Baltimore, Maryland, United States

Site Status

Greenbelt, Maryland, United States

Site Status

Detroit, Michigan, United States

Site Status

Southfield, Michigan, United States

Site Status

St Louis, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Billings, Montana, United States

Site Status

New Brunswick, New Jersey, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Milwaukee, Wisconsin, United States

Site Status

Calgary, Alberta, Canada

Site Status

Edmonton, Alberta, Canada

Site Status

Greater Sudbury, Ontario, Canada

Site Status

Caen, , France

Site Status

Montpellier, , France

Site Status

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Tübingen, Baden-Wurttemberg, Germany

Site Status

München, Bavaria, Germany

Site Status

München, Bavaria, Germany

Site Status

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Münster, North Rhine-Westphalia, Germany

Site Status

Rotterdam, , Netherlands

Site Status

Plymouth, Devon, United Kingdom

Site Status

Manchester, Greater Manchester, United Kingdom

Site Status

Cardiff, South Glamorgan, United Kingdom

Site Status

Sutton, Surrey, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada France Germany Netherlands United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

100386

Identifier Type: -

Identifier Source: org_study_id