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A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

Phase 3
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population

Outcome Description:

Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.

Outcome Time Frame:

From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2003

Completion Date:

April 2010

Related Keywords:

  • Carcinoma, Renal Cell
  • Renal Cell Cancer (RCC)
  • Cancer
  • Carcinoma
  • Carcinoma, Renal Cell



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