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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00111020
• Other study ID #: 11868
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2005
• Last updated: August 5, 2014
• Start date: June 2005
• Est. completion date: October 2008

Study information

• Verified date: August 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2567
• Est. completion date: October 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety parameters		From signing consent to 30 days after last dose of study drug	Yes
Secondary	Limited radiological evaluations		At baseline, than every 8 weeks after start of sorafenib	No

External Links

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