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Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

Randomized Discontinuation Study of BAY 43-9006 in Patients With Advanced Refractory Cancer.

Inclusion Criteria:

- Age > 18 years- Patients with refractory solid cancer for which curative or
palliative measures have failed or patients whose treatments are considered
ineffective or intolerable

- Patients with non-colorectal cancers are eligible and must be progressing at the time
of the screening assessment and for whom no other treatment exists

- Patients with at least one (1) measurable tumor, per the WHO Tumor Response Criteria
- Histological or cytological documentation of cancer- ECOG Performance status 0 or 1

- Life expectancy of at least 12 weeks- Adequate bone marrow, liver and renal function
(assessed by the following laboratory requirements):

- Hemoglobin >/= 9.0 g/dl - Absolute neutrophil count (ANC) >/=1,500/mm3

- Platelet count = 100,000/┬Ál3

- Total bilirubin
- ALT and AST of their cancer, ALT and AST < 5.0 x upper limit of normal)

- PT-INR/PTT < 1.5 x upper limit of normal. (Patients who are being therapeutically
anticoagulated with an agent such as coumadin or heparin will be allowed to
participate provided that no prior evidence of underlying abnormality in these
parameters exists.

In addition, these patients must be monitored with weekly coagulation assessments
throughout the Run-in Period)- Serum creatinine < 1.5 x upper limit of normal

Exclusion Criteria:

- Patients who meet the following criteria at the time of screening will be excluded:

- Non small cell lung cancer, hepatocellular cancer, CML and AML

- Serious cardiac arrhythmia

- Congestive Heart Failure (NYHA Class 3 or 4)

- Active of coronary artery disease or ischemia

- Active acute infections that could be worsened by anticancer therapy or interfere
with this study

- Known HIV infection

- 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 the tumor at the time of study entry

- Patients currently receiving medication (steroid or anticonvulsant therapy) for
seizure disorder

- History of organ allograft- Previous or concurrent cancer that is distinct from the
cancer being evaluated in this study. Several situations are excluded, including
cervical carcinoma in situ, adequately treated basal cell carcinoma, superficial
bladder tumors or any cancer definitively treated greater than 3 years

- Anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to
the first dose of study drug

- Radiotherapy during the study or within 3 weeks prior to the first dose of study drug

- Bone marrow transplant or stem cell rescue within 4 months prior to the first dose of
study drug

- Biological response modifiers, such as G-CSF within 3 weeks prior to study entry

- Patients taking chronic erythropoietin are permitted provided no dose adjustment is
undertaken within 2 months prior to the study or during the study

- Investigational drug therapy outside of this trial during or within 4 weeks prior to
the screening assessment

- Any previous exposure to a Ras pathway inhibitor

- Pregnant or breast feeding patients. Women of child bearing potential must have a
negative pregnancy test. Adequate barrier contraception will be required for both
male and female patients during the entire course of the trial

- Substance abuse, medical or 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 the trial

- Any condition that is unstable or could jeopardize the safety of the patient and/or
their compliance in the study

Type of Study:


Study Design:

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

Outcome Measure:

Number of progressions post randomization to placebo or sorafenib

Outcome Time Frame:

12 weeks post randomization

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2002

Completion Date:

January 2007

Related Keywords:

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



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