Research Study for Patients With Metastatic Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title:

A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00110344
• Other study ID #: 11547
• Status: Terminated
• Phase: Phase 2
• First received: May 6, 2005
• Last updated: October 10, 2013
• Start date: November 2005
• Est. completion date: June 2006

Study information

• Verified date: October 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Life expectancy of at least 12 weeks

• Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon

• At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen

• Patients who have an ECOG performance status of 0 or 1 Exclusion Criteria:

• History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation

• Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field

• Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• Nexavar (Sorafenib, BAY43-9006)
Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (Sorafenib, BAY 43-906; this arm) or matching placebo (see below) for 14 days. Dose range will be depending on hematologic and other toxicity between 400 mg (2 tablets of 200 mg) orally twice bid and 400 mg orally every 2 days. Cycle 2: patients who are eligible undergo nephrectomy. After the post-nephrectomy recovery period, all patients will receive 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.Cycle 3+: 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.
• Placebo
Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (see above) or matching placebo (this arm) for 14 days. Dose range will be depending on hematologic and other toxicity between 400mg (2 tablets of 200mg) orally twice bid and 400mg orally every 2 days. Cycle 2 and 3: see above (no placebo application)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response Rate (complete and partial response rate)		During study treatment or within 30 days after termination of active therapy	No
Secondary	Progression-free survival		Last date of tumor assessment	No
Secondary	Overall response rate		Last day of tumor assessement	No
Secondary	Time to response		throughout study	No
Secondary	Safety		all visits	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.