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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00044564
Recruitment Status : Completed
First Posted : September 4, 2002
Last Update Posted : December 19, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Bay 59-8862 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2001
Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044564

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00044564     History of Changes
Other Study ID Numbers: 100386
First Posted: September 4, 2002    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Renal Cell Carcinoma
Advanced Renal Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases