Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

Bayer

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Renal Cell

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00073307

11213

Details and patient eligibility

About

The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Full description

Overall Survival (OS), Patient-reported outcome (PRO)

Enrollment: 903 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
• Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
• Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
• Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
• Patients who have adequate coagulation, liver and kidney functions

Exclusion criteria

• Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors

• Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry

• Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure

• Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C

• Patients with a history or presence of metastatic brain or meningeal tumors

• Patients with seizure disorder requiring medication (such as anti-epileptics)

• History of organ allograft or bone marrow transplant of stem cell rescue

• Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control

• Patients who have three or more of the following:

  • ECOG performance status greater than or equal to 2,
  • Abnormally high lactate dehydrogenase,
  • Abnormally high serum hemoglobin,
  • Abnormally high corrected serum calcium,
  • Absence of prior nephrectomy

• Excluded therapies and medications, previous and concomitant:

  • Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
  • Significant surgery with 4 weeks of start of study
  • Investigational drug therapy during or within 30 days
  • Concomitant treatment with rifampin or St. John's Wort
  • Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
  • Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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903 participants in 2 patient groups, including a placebo group

Sorafenib (Nexavar, BAY43-9006)

Experimental group

Description:

Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.

Treatment:

Drug: Sorafenib (Nexavar, BAY43-9006)

Placebo

Placebo Comparator group

Description:

Placebo tablets matching in appearance were to be orally administered twice a day.

Treatment:

Drug: Placebo