check_circleStudy Completed

Neoplasm, Metastasis

Bayer Identifier:

10922

ClinicalTrials.gov Identifier:

NCT00657254

EudraCT Number:

Not Available

EU CT Number:

Not Available
Extension Program for Bay 43-9006

Trial purpose

The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients who had participated in a previous sorafenib study that had completed, who did not meet withdrawal criteria of the previous study and who were, in the opinion of the investigator and sponsor still benefiting from treatment.
  • - The current cardiovascular situation of the patient was carefully re-evaluated by both the investigator and the sponsor and an informed decision as to inclusion was then made.- Substance abuse, medical, psychological or social conditions that may have interfered with the patient's participation in the study or evaluation of the study results.- Known or suspected allergy to the investigational agent.- Any condition that was unstable or which could jeopardise the safety of the patient and his/her compliance in the study.

Trial summary

Enrollment Goal
9
Trial Dates
December 2002 - June 2005
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Toronto, M5G 2M9, Canada
Withdrawn
Herne, 44625, Germany
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
Hamilton, L8V 5C2, Canada
Completed
Essen, 45147, Germany
Completed
Boston, 02115-6084, United States

Primary Outcome

  • Survival
    date_rangeTime Frame:
    Death
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    Safety Issue:
    no

Secondary Outcome

  • Objective Tumour Response Rate
    date_rangeTime Frame:
    Number of confirmed partial and complete responses
    enhanced_encryption
    Safety Issue:
    no
  • Overall Response Duration
    date_rangeTime Frame:
    Time from the date of the first intake of sorafenib to the date that progressive disease is documented.
    enhanced_encryption
    Safety Issue:
    no
  • Time to Objective Response
    date_rangeTime Frame:
    Time from the date of the first intake of sorafenib to the date that objective response is first documented.
    enhanced_encryption
    Safety Issue:
    no
  • Time to Disease Progression
    date_rangeTime Frame:
    Time from first intake of sorafenib to disease progression
    enhanced_encryption
    Safety Issue:
    no
  • Safety Parameters
    date_rangeTime Frame:
    Throughout study
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    Safety Issue:
    yes

Trial design

Extension Program for Bay 43-9006
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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