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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259129
• Other study ID #: 100561
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2005
• Last updated: November 11, 2014
• Start date: August 2005
• Est. completion date: March 2008

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg twice a day (bid) (2 x 200 mg tablets)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of sorafenib on cardiovascular safety parameters		up to 2 months	Yes
Secondary	Pharmacokinetics		after 16 months	No
Secondary	Anti-tumor activity		after 10 months	No
Secondary	Adverse Event Collection		after 11 months	Yes

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