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Completed

NCT Number: NCT00259129

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

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

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Sorafenib 400 mg twice a day (bid) (2 x 200 mg tablets)

Primary outcomes

  1. Effect of sorafenib on cardiovascular safety parameters

    Time frame: up to 2 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Nov 29, 2005
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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