Trial Condition(s):

Carcinoma, Renal Cell

Sorafenib Dose Escalation in Renal Cell Carcinoma

Bayer Identifier:

12913 Identifier:


EudraCT Number:


EU CT Number:

Not Available

Study Completed

Trial Purpose

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.
This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient’s tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient’s treatment, as long as the patient is not experiencing side effects and the patient’s tumor has not grown.

Inclusion Criteria
- Age > 18 years. 
- Metastatic clear cell RCC (renal cell carcinoma)
- Subjects with at least one uni-dimensional  
  measurable lesion. 
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Memorial Sloan Kettering Cancer Center (MSKCC) good or intermediate category
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to treatment
- Signed informed consent must be obtained prior to any study specific procedures.
- Subjects must have received no prior systemic anticancer therapy for the treatment of their renal cell carcinoma
- Prior total nephrectomy
Exclusion Criteria
- History of cardiac disease
- History of human immunodeficiency virus (HIV) infection or chronic hepatitis 
  B or C 
- Active clinically serious infections (> grade 2 National Cancer
Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 3.0) 
- Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry.  
- Subjects with evidence or history of bleeding diathesis
- Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of treatment.
- Delayed healing of wounds, ulcers or bone fractures
- Subjects with pre-existing thyroid abnormality whose thyroid function cannot be maintained within the normal range by medication 
- Subjects undergoing renal dialysis
- Pregnant or breast-feeding subjects.  Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.  Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and three months after the completion of trial.   
- Prior adjuvant sorafenib is excluded.
- Radiotherapy during study or within 3 weeks of start of study drug
- Major surgery within 4 weeks of start of study 
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry

Trial Summary

Enrollment Goal
Trial Dates
Could I receive a placebo?
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers

Where to Participate


Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131


Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076


Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35043


Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625


Christie Hospital

Greater Manchester, United Kingdom, M20 4BX


Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN


Velindre Hospital

Cardiff, United Kingdom, CF14 7TB


Hôpital de la Timone - Marseille

MARSEILLE, France, 13385


Hôpital Saint André - Bordeaux

BORDEAUX, France, 33000


Centre Hospitalier Départemental-La Roche sur Yon

LA ROCHE SUR YON, France, 85925


Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781


Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, Poland, 50 - 556


IRCCS Istituto Nazionale Tumori

Milano, Italy, 20133


Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07740


Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ


Hôpital Bretonneau - Tours

TOURS, France, 37044


Centre René Gauducheau - Nantes

NANTES, France, 44805


Hôpital Saint Louis - Paris

PARIS CEDEX 10, France, 75475


Wojskowy Instytut Medyczny

Warszawa, Poland, 04-141



Olsztyn, Poland, 10-226


IRCCS Centro di Riferimento Oncologico - CRO

Aviano, Italy, 33081


IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Trial Design