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An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma

Phase 3
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

An Open Label, Non Comparative, Phase III Study of the Raf Kinase Inhibitor BAY 43-9006 as a Subsequent to First Line Therapy in Patients With Advanced Renal Cell Carcinoma

Inclusion Criteria:

- The patient must provide written informed consent prior to receiving BAY 43-9006

- The male or female patient must be at least 18 years of age

- The patient must have advanced Renal Cell Carcinoma

- The patient must have failed at least one prior systemic established therapy for
advanced RCC (e. g. IL-2, IFN-a), or must have been unable to tolerate systemic
therapy for advanced RCC, or is deemed by the Investigator to be unsuited for
systemic therapy for advanced RCC

- A patient, who has received prior systemic and local therapies, must have completely
recovered from acute toxicity (i. e. resolved back to CTCAE Grade 1 or less, or is
considered as not going to resolve), if any, prior to study entry

- The patient must be, in the Investigator's opinion, reasonably likely to benefit from
treatment with BAY 43-9006 as a single agent

- The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0-2

- The patient will not require other systemic anti-cancer chemotherapy, immunotherapy
(including monoclonal antibodies) or hormonal therapy, except for bisphosphonates
while taking BAY 43-9006

- Both male and female patients must use adequate barrier birth control methods (oral
contraceptives, injectable contraceptives, intrauterine devices, condoms,
sterilization) during their participation in the protocol. The birth control methods
must be used for 4 weeks for female patients and for 3 months for male patients after
discontinuation of treatment with sorafenib

- For patients, who have had major surgery, the wound must be completely healed prior
to receiving BAY 43-9006 treatment (4 weeks)

Exclusion Criteria:

- Patients who are currently enrolled in or have previously participated in any other
sorafenib trial

- Patients, who are eligible for or do have access to any other sorafenib clinical
trial as to the knowledge of the Investigator

- Patients who have a life expectancy of less than 2 months

- Patients with metastatic brain or meningeal tumors

- Patients are excluded who require any of the following:

- Investigational drug therapy during the treatment with sorafenib or within 30 days
prior to their first dose of sorafenib

- Concomitant Rifampicin

- Concomitant St. John's Wort (Hypericum perforatum) Warfarin is allowed; however, for
patients receiving concomitant warfarin therapy close monitoring of Prothrombin Time
(PT) should be performed (please note that no laboratory data are collected in this

- Women who are pregnant or breast-feeding. Women of childbearing potential must have a
negative pregnancy test performed within seven days of the start of study drug
(please note that no laboratory data are collected in this study)

- Patients with congestive heart failure greater than NYHA functional class II
(symptomatic during ordinary activity)

- Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0
(conduction abnormality and supraventricular arrhythmia present but patient is
asymptomatic; intervention not indicated, palpitations present and QTc > 0.45-0.47

- Patients with active coronary artery disease or ischemia

- Patients with Child-Pugh class C hepatic impairment

- Patients with severe renal impairment (calculated creatinine clearance of < 30
ml/min) or who require dialysis

- Patients with active uncontrolled hypertension

- Patients with recent or active bleeding diathesis

- Patients with any medical condition which could jeopardize their safety while taking
an investigational drug

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety Parameters

Outcome Time Frame:


Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2005

Completion Date:

November 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Renal Cell Cancer (RCC)
  • Cancer
  • Carcinoma
  • Carcinoma, Renal Cell