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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259129
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : November 13, 2014
Information provided by (Responsible Party):

Brief Summary:
This is an open-label, non-randomized Phase I study of sorafenib 400 mg bid (2 x 200 mg tablets) in cancer patients. The primary objective of the study is to evaluate the effect of sorafenib on cardiovascular safety parameters. The secondary objectives are to evaluate the safety, pharmacokinetics, and anti-tumor activity of sorafenib in cancer patients

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Sorafenib (Nexavar, BAY43-9006) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients
Study Start Date : August 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice a day (bid) (2 x 200 mg tablets)

Primary Outcome Measures :
  1. Effect of sorafenib on cardiovascular safety parameters [ Time Frame: up to 2 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: after 16 months ]
  2. Anti-tumor activity [ Time Frame: after 10 months ]
  3. Adverse Event Collection [ Time Frame: after 11 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 intolerable
  • 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 antihypertensives
  • Symptomatic metastatic brain or meningeal tumors
  • Pregnant or breast-feeding patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259129

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United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Publications of Results:
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Responsible Party: Bayer Identifier: NCT00259129    
Other Study ID Numbers: 100561
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action