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OpenTrials
Completed

NCT Number: NCT00657254

Extension Program for Bay 43-9006

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.

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Key information

Conditions

Neoplasm Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bruxelles - Brussel, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nexavar (Sorafenib, BAY43-9006)

Drug

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

Primary outcomes

  1. Survival

    Time frame: Death

Secondary outcomes

  1. Objective Tumour Response Rate

    Time frame: Number of confirmed partial and complete responses

  2. Overall Response Duration

    Time frame: Time from the date of the first intake of sorafenib to the date that progressive disease is documented.

  3. Time to Objective Response

    Time frame: Time from the date of the first intake of sorafenib to the date that objective response is first documented.

  4. Time to Disease Progression

    Time frame: Time from first intake of sorafenib to disease progression

  5. Safety Parameters

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Apr 14, 2008
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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