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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: Sorafenib (Nexavar, BAY43-9006)

• Registration Number: NCT00259129
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-11-29
• Primary Completion: 2007-02
• Study Completion: 2008-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-11
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Sorafenib (Nexavar, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Effect of sorafenib on cardiovascular safety parameters	up to 2 months

Secondary Outcome Measures

Name	Time	Method
Adverse Event Collection	after 11 months
Anti-tumor activity	after 10 months
Pharmacokinetics	after 16 months