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

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