Research Study for Patients With Metastatic Renal Cell Carcinoma

Bayer

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Nexavar (Sorafenib, BAY43-9006); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00110344

11547

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Nexavar (Sorafenib, BAY43-9006)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo