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

Phase 3
15 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

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

Inclusion Criteria:

- Patients with advanced (unresectable, recurrent or metastatic) RCC

- Patients reasonably likely to benefit from treatment with sorafenib as a single agent

- 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

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:

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

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

October 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Carcinoma
  • Carcinoma, Renal Cell



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