BAY43-9006 Phase II Study for Renal Cell Carcinoma

Bayer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661375

11515

Details and patient eligibility

About

To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented.
• Patients with rare subtypes of RCC, such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors, are excluded from study participation.

Exclusion criteria

• More than three regimens of previous treatment for RCC

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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131 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Nexavar (Sorafenib, BAY43-9006)