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Extension Program for Bay 43-9006

NCT ID: NCT00657254

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasm Metastasis

Keywords

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Extension Sorafenib Survival

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Nexavar (Sorafenib, BAY43-9006)

Intervention Type DRUG

Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.

Interventions

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Nexavar (Sorafenib, BAY43-9006)

Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - 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.

Exclusion Criteria

Exclusion Criteria:- 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Boston, Massachusetts, United States

Site Status

Bruxelles - Brussel, , Belgium

Site Status

Hamilton, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Essen, North Rhine-Westphalia, Germany

Site Status

Herne, North Rhine-Westphalia, Germany

Site Status

Countries

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United States Belgium Canada Germany

Other Identifiers

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10922

Identifier Type: -

Identifier Source: org_study_id