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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00259129
First received: November 28, 2005
Last updated: November 11, 2014
Last verified: November 2014
  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
Neoplasms
Drug: Sorafenib (Nexavar, BAY43-9006)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Effect of sorafenib on cardiovascular safety parameters [ Time Frame: up to 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: after 16 months ] [ Designated as safety issue: No ]
  • Anti-tumor activity [ Time Frame: after 10 months ] [ Designated as safety issue: No ]
  • Adverse Event Collection [ Time Frame: after 11 months ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: August 2005
Study Completion Date: March 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice a day (bid) (2 x 200 mg tablets)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259129

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

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00259129     History of Changes
Other Study ID Numbers: 100561
Study First Received: November 28, 2005
Last Updated: November 11, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014