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NCT00625378 · ClinicalTrials.gov registry record · Phase 3
Sorafenib Long Term Extension Program
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 206
- Enrollment target
NCT00625378 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 206 participants.
The verdict
NCT00625378, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 206 participants
- Enrollment target
Study Summary
The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib. An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.
Interventions
- DRUG Sorafenib (Nexavar, BAY43-9006)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2007-12-21 |
| Est. Completion | 2021-09-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00625378
The ClinicalTrials.gov registry entry for NCT00625378 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sorafenib (Nexavar, BAY43-9006) is the first listed.
NCT00625378 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00625378 about?
NCT00625378 is a clinical study titled "Sorafenib Long Term Extension Program". The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients ...
What is the current status of trial NCT00625378?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2007-12-21. Estimated completion is 2021-09-24.
What interventions are being tested in trial NCT00625378?
The interventions under investigation include: Sorafenib (Nexavar, BAY43-9006) (DRUG).
Who is sponsoring clinical trial NCT00625378?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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