Status:
COMPLETED
Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients
Lead Sponsor:
Bayer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 cardio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00259129
Start Date
August 1 2005
End Date
March 1 2008
Last Update
November 13 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston, Massachusetts, United States, 02115
2
San Antonio, Texas, United States, 78229