Know Cancer

forgot password

Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients

Inclusion Criteria:

- Patients with refractory solid cancer for which curative or palliative measures have
failed or patients for whom standard treatment is considered ineffective or

- Histological or cytological documentation of cancer is required

- Patients with at least one evaluable lesion. Lesions must be evaluated by Computed
Tomography (CT) scan or Magnetic Resonance Imaging (MRI)

- Life expectancy of at least 12 weeks

- Left ventricular ejection fraction (LVEF) >=45 % as assessed at the Baseline Multiple
Gated Acquisition (MUGA) scan

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

- Hemoglobin > 9.0 g/dL

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

- Platelet count >=100,000/dL

- Total bilirubin <=1.5 times the upper limit of normal

- Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <=2.5 x
upper limit of normal, except if there is metastatic disease to the liver, in
which case <=5 x upper limit of normal is acceptable

- Prothrombin Time-International Normalized Ratio/Partial Thromboplastin Time
(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. For patients on anticoagulation therapy, at least
weekly evaluations will be performed until International Normalized Ratio (INR)
is stable as defined by the local standard of care

- Serum creatinine <=1.5 x upper limit of normal

Exclusion Criteria:

- Colorectal cancer whether refractory or not

- Supine systolic blood pressure greater than 170 mmHg or diastolic blood pressure
greater than 100 mmHg (mean of duplicate readings) at Screening with or without

- Symptomatic metastatic brain or meningeal tumors

- Pregnant or breast-feeding patients

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Effect of sorafenib on cardiovascular safety parameters

Outcome Time Frame:

up to 2 months

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

March 2008

Related Keywords:

  • Neoplasms
  • Neoplasms



Austin, Texas  78705
Boston, Massachusetts