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Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients
This study is currently recruiting participants.
Verified by Bayer, January 2009
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00259129
  Purpose

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 Intervention Phase
Cancer
Drug: BAY 43-9006 (sorafenib)
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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 CT scan or MRI
  • Life expectancy of at least 12 weeks
  • LVEF >=45 % as assessed at the Baseline 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
    • ALT and 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
    • 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259129

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andrew Wolanski, NP     617-632-6623     awolanski@partners.org    
Contact: Leonard J. Appleman            
United States, Texas
The Institute for Drug Development Recruiting
San Antonio, Texas, United States, 78229-4427
Contact: Epp Goodwin     210-616-5768     egoodwin@ctrc.net    
Contact: Anthony Tolcher, MD            
Sponsors and Collaborators
Bayer
  More Information

Study ID Numbers: 100561
Study First Received: November 28, 2005
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00259129  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Sorafenib

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009