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

NCT ID: NCT00259129

Last Updated: 2014-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2008-03-31

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

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Sorafenib (Nexavar, BAY43-9006)

Intervention Type: DRUG

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

Interventions

Sorafenib (Nexavar, BAY43-9006)

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Boston, Massachusetts, United States

San Antonio, Texas, United States

Countries

United States

References

Tolcher AW, Appleman LJ, Shapiro GI, Mita AC, Cihon F, Mazzu A, Sundaresan PR. A phase I open-label study evaluating the cardiovascular safety of sorafenib in patients with advanced cancer. Cancer Chemother Pharmacol. 2011 Apr;67(4):751-64. doi: 10.1007/s00280-010-1372-3. Epub 2010 Jun 3.

Reference Type: RESULT

PMID: 20521052 (View on PubMed)

Other Identifiers

100561

Identifier Type: -

Identifier Source: org_study_id