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Extension Program for Bay 43-9006

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Bayer

Status and phase

Completed
Phase 2

Conditions

Neoplasm
Metastasis

Treatments

Drug: Nexavar (Sorafenib, BAY43-9006)

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:- 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 design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Arm 1
Experimental group
Treatment:
Drug: Nexavar (Sorafenib, BAY43-9006)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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