stop_circleTerminated/Withdrawn

Carcinoma, Renal Cell

Phase IV Randomization to On-Going Treatment to Evaluate Sustained Sorafenib

Trial purpose

The purpose of this study is to see if taking interferon or gemcitabine along with sorafenib will stop the advanced renal cell cancer from becoming worse in some people. To do this, sorafenib along with gemcitabine or interferon will be compared to treatment with gemcitabine or interferon alone. More safety information on sorafenib will be also collected. About 260 patients with progressed renal cell cancer will be in this study.

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
2
Trial Dates
August 2006 - November 2006
Phase
Phase 4
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kansas City, United States

Primary Outcome

  • Progression Free Survival (PFS)
    date_rangeTime Frame:
    After 192 progression or death events
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    Safety Issue:
    None

Secondary Outcome

  • Disease Control Rate (DCR)
    date_rangeTime Frame:
    After start of treatment
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    Safety Issue:
    None
  • Overall Best Response
    date_rangeTime Frame:
    Until 30 days after termination of active therapy
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    Safety Issue:
    None
  • Duration of response
    date_rangeTime Frame:
    Time from initial Response to documented Tumor Progression
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    Safety Issue:
    None
  • Time to response
    date_rangeTime Frame:
    Time from the date of randomization to date that an objective tumor response (PR or CR) according to RECIST criteria is first documented
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    Safety Issue:
    None
  • Overall Survival (OS)
    date_rangeTime Frame:
    Time from the date of randomization to date of death
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    Safety Issue:
    None
  • Adverse Event Collection and Tolerability
    date_rangeTime Frame:
    Throughout the whole study
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    Safety Issue:
    None

Trial design

A Randomized Discontinuation Trial to Determine the Clinical Benefit of Continuation of Sorafenib Following Disease Progression in Patients With Advanced Renal Cell Carcinoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2