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

NCT00259129 | Completed Phase 1

• 1 other identifier: 100561
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Effect of sorafenib on cardiovascular safety parameters

  up to 2 months

Secondary Outcomes (3)

• Pharmacokinetics

  after 16 months

• Anti-tumor activity

  after 10 months

• Adverse Event Collection

  after 11 months

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Related 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/s00280-010-1372-3. Epub 2010 Jun 3.

  PMID: 20521052 RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: November 29, 2005
• Study Start: August 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: March 1, 2008
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

US (2)