NCT00044564

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2001

Shorter than P25 for phase_2

Geographic Reach
6 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2002

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

First QC Date

August 30, 2002

Last Update Submit

December 18, 2014

Conditions

Carcinoma, Renal Cell

Keywords

TaxaneRenal Cell CarcinomaAdvanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

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

    At baseline and every 2 cycles during the treatment period

Secondary Outcomes (8)

  • Duration of response

    At baseline and every cycle during the treatment period

  • Overall survival

    Till end of follow up period (up to 2 years)

  • Time to progression

    Throughout study

  • Pharmacokinetics assessment

    At cycle 1

  • Qualitative and quantitative toxicity profile

    Day 1 of each cycle or as clinically indicated

  • +3 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Bay 59-8862

Interventions

Bay 59-8862DRUG

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

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Unknown Facility

La Jolla, California, 92037, United States

Location

Unknown Facility

Muncie, Indiana, 47304, United States

Location

Unknown Facility

New Orleans, Louisiana, 70121-2484, United States

Location

Unknown Facility

Baltimore, Maryland, 21201-1595, United States

Location

Unknown Facility

Greenbelt, Maryland, 20770, United States

Location

Unknown Facility

Detroit, Michigan, 48201-9027, United States

Location

Unknown Facility

Southfield, Michigan, 48075, United States

Location

Unknown Facility

St Louis, Missouri, 63104, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Billings, Montana, 59101, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08901, United States

Location

Unknown Facility

Salt Lake City, Utah, 84108, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 53226, United States

Location

Unknown Facility

Calgary, Alberta, T2N 4N2, Canada

Location

Unknown Facility

Edmonton, Alberta, T6G 1Z2, Canada

Location

Unknown Facility

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Unknown Facility

Caen, 14076, France

Location

Unknown Facility

Montpellier, 34298, France

Location

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Unknown Facility

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Unknown Facility

München, Bavaria, 81377, Germany

Location

Unknown Facility

München, Bavaria, 81675, Germany

Location

Unknown Facility

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Unknown Facility

Münster, North Rhine-Westphalia, 48149, Germany

Location

Unknown Facility

Rotterdam, 3015 GD, Netherlands

Location

Unknown Facility

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Unknown Facility

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Unknown Facility

Cardiff, South Glamorgan, CF14 2TL, United Kingdom

Location

Unknown Facility

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

IDN 5109

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2002

First Posted

September 4, 2002

Study Start

December 1, 2001

Study Completion

January 1, 2003

Last Updated

December 19, 2014

Record last verified: 2014-12

Locations

US(13)CA(3)DE(6)NL(1)GB(4)FR(2)