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A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

Thank you

Trial Information

A Randomised, Open-label, Multi-centre Phase II Study of BAY43-9006 (Sorafenib) Versus Standard Treatment With Interferon Alpha-2a in Patients With Unresectable and/or Metastatic Renal Cell Carcinoma.

Analyses on Biomarkers were exploratory and assessed as tertiary objective of the trial.

Inclusion Criteria:

- Patients who give written informed consent prior to any study specific screening
procedures with the understanding that the patient has the right to withdraw from the
study at any time, without prejudice

- Male or female patients >= 18 years of age

- Patients who have a life expectancy of at least 12 weeks

- Patients, who suffer from unresectable and/or metastatic, measurable predominantly
clear cell RCC (Renal Cell Carcinoma) histologically or cytologically documented

- Patients must have undergone prior (at the time of primary diagnosis) complete
surgical excision of primary RCC tumor

- Patients must have had no prior systemic therapy for advanced RCC. Prior systemic
therapy is defined as any treatment with a chemotherapy agent (or regimen), an
immunotherapy agent (or regimen) or an investigational treatment agent (or regimen)
against the renal cell carcinoma. Megestrol acetate or medroxyprogesterone will
constitute as a prior systemic therapy

- Patients who have at least one uni-dimensional measurable lesion by CT (Computed
tomography)-scan or MRI (Magnetic resonance imaging) 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

- Adequate bone marrow, liver , and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to screening

- Hemoglobin >9.0 g/l

- Absolute neutrophil count ( ANC)>1,500/mm3

- Platelets> or = 100,000/ul

- Total bilirubin < 1.5 x the upper limit of normal

- ALT (Alanine aminotransferase) and AST (Aspartate aminotransferase) < 2.5 x upper
limit of normal (< 5 x upper limit of normal for patients with liver involvement of
their cancer)

- Amylase and lipase < 1.5 x the upper limit of normal

- Serum creatinine < 2.0 x the upper limit of normal

- PT (Prothrombin Time) or INR (International Normalized Ratio) and PTT (Partial
Thromboplastin Time) < 1.5 x upper limit of normal (patients who receive
anti-coagulation treatment with an agent such as warfarin or heparin will be allowed
to participate. For patients on warfarin, close monitoring of at least weekly
evaluations will be performed until INR is stable based on a measurement at pre dose,
as defined by the local standard of care)

Exclusion Criteria:

- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis
[Carcinoma in situ: "flat tumor"]&T1 [Tumor invades subepithelial connective tissue])
or any cancer curatively treated > 5 years prior to study entry

- Complete renal shut-down requiring hemo- or peritoneal dialysis

- History of cardiac disease : congestive heart failure > NYHA (New York Heart
Association) class 2: active cardiovascular disease( MI (Distant metastasis) more
than 6 months prior to study entry is allowed); cardiac arrhythmia requiring
anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled

- Active clinically serious bacterial or fungal infections (>= grade 2 NCI-CTCAE
(National Cancer Institute-Common Terminology Criteria for Adverse Events), Version

- Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B
or C

- Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months
from definitive therapy, has a negative imaging study within 4 weeks of study entry
and is clinically stable with respect to this brain tumour site at the time of study
entry. Also the patient must not be undergoing acute steroid therapy or taper
(chronic steroid therapy is acceptable provided that the dose is stable for one month
prior to and following screening radiographic studies (head CT or MRI at screening
always required)

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

- History of organ allograft

- Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

- Known or suspected allergy to the investigational agent or any agent given in
association with this trial

- Any condition that is unstable or which could jeopardise the safety of the patient
and his/her compliance in the study

- Pregnant or breast-feeding patients. Women of childbearing potential must have a
negative pregnancy test performed within 7 days of the start of treatment. Both men
and women enrolled in this trial must use adequate barrier birth control measures
during the course of the trial

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) Based on Independent Radiological Review for the First Intervention Period

Outcome Description:

Progression-free Survival (PFS) was defined as the time from date of randomization to disease progression (radiological or clinical or death due to any cause, whichever occurs first). Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation

Outcome Time Frame:

From randomization of the first subject until 15 months later, assessed every 8 weeks

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

March 2009

Related Keywords:

  • Carcinoma, Renal Cell
  • Renal Cell Cancer
  • RCC
  • Cancer
  • Carcinoma
  • Carcinoma, Renal Cell



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