check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

100386

ClinicalTrials.gov Identifier:

NCT00044564

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of Bay 59-8862 in Patients with Advanced Renal Cell Carcinoma

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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.

Trial summary

Enrollment Goal
54
Trial Dates
December 2001 - January 2003
Phase
Phase 2
Could I Receive a placebo
No
Products
Cytotoxic Taxane (BAY59-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Sudbury, P3E 5J1, Canada
Completed
Calgary, T2N 4N2, Canada
Completed
München, 81675, Germany
Withdrawn
Baltimore, 21201-1595, United States
Completed
Edmonton, T6G 1Z2, Canada
Withdrawn
Münster, 48149, Germany
Withdrawn
Plymouth, PL6 8DH, United Kingdom
Completed
Manchester, M20 4BX, United Kingdom
Completed
La Jolla, 92037, United States
Withdrawn
St. Louis, 63110, United States
Withdrawn
Milwaukee, 53226, United States
Completed
Salt Lake City, 84112, United States
Withdrawn
Detroit, 48201-9027, United States
Withdrawn
St. Louis, 63104, United States
Withdrawn
New Brunswick, 08901-1914, United States
Completed
Düsseldorf, 40225, Germany
Completed
CAEN CEDEX 5, 14076, France
Withdrawn
Sutton, SM2 5PT, United Kingdom
Withdrawn
ROTTERDAM, 3015 GD, Netherlands
Completed
Billings, 59101, United States
Completed
MONTPELLIER CEDEX, 34298, France
Withdrawn
Cardiff, CF14 2TL, United Kingdom
Withdrawn
Southfield, 48075, United States
Completed
Heidelberg, 69112, Germany
Withdrawn
New Orleans, 70121, United States
Withdrawn
München, 81377, Germany
Withdrawn
Tübingen, 72076, Germany
Withdrawn
Greenbelt, 20770, United States
Completed
Muncie, 47304, United States

Primary Outcome

  • Objective overall tumor response rate calculated as the percentage of patients with complete and partial responses
    date_rangeTime Frame:
    At baseline and every 2 cycles during the treatment period
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    Safety Issue:
    None

Secondary Outcome

  • Duration of response
    date_rangeTime Frame:
    At baseline and every cycle during the treatment period
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    Safety Issue:
    None
  • Overall survival
    date_rangeTime Frame:
    Till end of follow up period (up to 2 years)
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    Safety Issue:
    None
  • Time to progression
    date_rangeTime Frame:
    Throughout study
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    Safety Issue:
    None
  • Pharmacokinetics assessment
    date_rangeTime Frame:
    At cycle 1
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    Safety Issue:
    None
  • Qualitative and quantitative toxicity profile
    date_rangeTime Frame:
    Day 1 of each cycle or as clinically indicated
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    Safety Issue:
    None
  • Physical examinations
    date_rangeTime Frame:
    As clinically indicated
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    Safety Issue:
    None
  • Vital signs data
    date_rangeTime Frame:
    Throughout study period
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    Safety Issue:
    None
  • Abnormal laboratory tests
    date_rangeTime Frame:
    Prior to every cycle till last study visit
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    Safety Issue:
    None

Trial design

An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients with Advanced Renal Cell Carcinoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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