Extension Program for Bay 43-9006

Metastasis Clinical Trial

Official title:

Extension Program for Bay 43-9006

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657254
• Other study ID #: 10922
• Status: Completed
• Phase: Phase 2
• First received: April 8, 2008
• Last updated: December 18, 2014
• Start date: December 2002
• Est. completion date: June 2005

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastasis
• Neoplasm

Intervention

Drug:
• Nexavar (Sorafenib, BAY43-9006)
Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		Death	No
Secondary	Objective Tumour Response Rate		Number of confirmed partial and complete responses	No
Secondary	Overall Response Duration		Time from the date of the first intake of sorafenib to the date that progressive disease is documented.	No
Secondary	Time to Objective Response		Time from the date of the first intake of sorafenib to the date that objective response is first documented.	No
Secondary	Time to Disease Progression		Time from first intake of sorafenib to disease progression	No
Secondary	Safety Parameters		Throughout study	Yes

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