Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with advanced (unresectable, recurrent or metastatic) RCC
Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy
Patients with an ECOG performance status of 0-2
Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib
Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice

Exclusion criteria

Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
Patients who have participated in any other sorafenib trial
Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
Life expectancy of less than two months
Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
Patients with active coronary artery disease or ischemia
Patients with Child-Pugh class C hepatic impairment
Patients with severe renal impairment or who require dialysis
Patients with active uncontrolled hypertension
Patients with recent or active bleeding diathesis

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Multi kinase inhibitor: 400 mg of Sorafenib, orally, twice a day, on a continuous basis as a single agent for the treatment of advanced RCC

Primary outcomes

Safety parameters

Time frame: From signing consent to 30 days after last dose of study drug

Secondary outcomes

Limited radiological evaluations

Time frame: At baseline, than every 8 weeks after start of sorafenib

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients With Advanced Renal Cell Carcinoma

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2008
First posted: May 17, 2005
Registry last updated: Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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