check_circleStudy Completed

Carcinoma, Renal Cell

Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer

Trial purpose

The purpose of the study is to:
- Find out if BAY 43-9006 prevents the growth of tumors
- For patients who have stable cancer status after 3 months of treatment if it is safer and/or more effective to continue to give BAY 43-9006 or to stop giving BAY 43-9006 at that time.
- Find out how long the effect of BAY 43-9006 is on tumors. To assess the safety of BAY 43-9006 (sorafenib) in the treatment of advanced refractory cancers.
- Measure the amount of BAY 43-9006 and some of its targets in the blood stream in some patients.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
501
Trial Dates
September 2002 - January 2007
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
M. D. Anderson Cancer Center - University of TexasHouston, 77030, United States
Completed
University of PennsylvaniaPhiladelphia, 19104, United States
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
University of ChicagoChicago, 60637, United States
Terminated
Western InfirmaryGlasgow, G11 6NT, United Kingdom
Completed
Institute for Drug DevelopmentSan Antonio, 78229, United States
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom

Primary Outcome

  • Number of progressions post randomization to placebo or sorafenib
    date_rangeTime Frame:
    12 weeks post randomization
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Time to progression
    date_rangeTime Frame:
    Until Progression occurs
    enhanced_encryption
    Safety Issue:
    None
  • Duration of objective tumor response
    date_rangeTime Frame:
    Time from initial Response to documented Tumor Progression
    enhanced_encryption
    Safety Issue:
    None
  • Overall survival time
    date_rangeTime Frame:
    At the End-of-Study visit
    enhanced_encryption
    Safety Issue:
    None

Trial design

Randomized Discontinuation Study of BAY 43-9006 in patients with Advanced Refractory Cancer.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2