Trial Condition(s):

Neoplasms

Effect of BAY 43-9006 (sorafenib) on cardiovascular safety parameters in cancer patients

Bayer Identifier:

100561

ClinicalTrials.gov Identifier:

NCT00259129

EudraCT Number:

Not Available

Study Completed

Trial 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

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

Trial Summary

Enrollment Goal
53
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Dana-Farber Cancer Institute

Boston, United States, 02115

Status
Completed
 
Locations

Institute for Drug Development

San Antonio, United States, 78229

Status
Completed
 

Trial Design