check_circleStudy Completed

Neoplasms

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

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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
August 2005 - March 2008
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Dana-Farber Cancer InstituteBoston, 02115, United States
Completed
Institute for Drug DevelopmentSan Antonio, 78229, United States

Primary Outcome

  • Effect of sorafenib on cardiovascular safety parameters
    date_rangeTime Frame:
    up to 2 months
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Pharmacokinetics
    date_rangeTime Frame:
    after 16 months
    enhanced_encryption
    Safety Issue:
    no
  • Anti-tumor activity
    date_rangeTime Frame:
    after 10 months
    enhanced_encryption
    Safety Issue:
    no
  • Adverse Event Collection
    date_rangeTime Frame:
    after 11 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Effect of BAY 43-9006 (sorafenib) on cardiovascular safety parameters in cancer patients
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1