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

Phase 2

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Bay 59-8862

• Registration Number: NCT00044564
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-08-30
• Study First Submitted QC: 2002-09-03
• Study First Posted: 2002-09-04
• Study Completion: 2003-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Bay 59-8862	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Physical examinations	As clinically indicated
Vital signs data	Throughout study period
Abnormal laboratory tests	Prior to every cycle till last study visit