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

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Trial Conditions
  • Carcinoma, Renal Cell
What is the purpose of this trial?

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY 43-9006, 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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
15 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Bayer Study Director
Trial Interventions
Drug
  • Sorafenib (Nexavar, BAY43-9006)
Physician Researcher

Investigator Name:

  • Bayer Study Director

Other Information

Sponsor: Bayer
Phase: Phase 3
Trial ID: NCT00111020
Volunteers:  Not Accepting Healthy Volunteers

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