Clinical trial NCT00259129: Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients
Official title: Effect of BAY 43-9006 (Sorafenib) on Cardiovascular Safety Parameters in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-11-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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


Eligibility criteria: 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

Primary outcomes:
measure: Effect of sorafenib on cardiovascular safety parameters
timeFrame: up to 2 months
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: after 16 months
measure: Anti-tumor activity
timeFrame: after 10 months
measure: Adverse Event Collection
timeFrame: after 11 months
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.