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NCT00941863 · ClinicalTrials.gov registry record · Phase 1
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
NCT00941863 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 158 participants.
The verdict
NCT00941863, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
Study Summary
The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors. The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.
Interventions
- DRUG Sorafenib 100 mg (50-mg tablet)
- DRUG Sorafenib 200 mg (50-mg tablet)
- DRUG Sorafenib 400 mg (50-mg tablet)
- DRUG Sorafenib 400 mg (200-mg tablet)
- DRUG Sorafenib 400 mg (Expansion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2002-07 |
| Est. Completion | 2008-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00941863
The ClinicalTrials.gov registry entry for NCT00941863 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 158 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 5 interventions - of which Sorafenib 100 mg (50-mg tablet) is the first listed.
NCT00941863 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00941863 about?
NCT00941863 is a clinical study titled "Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)". The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors. The secondary objectives were evaluation of pharmacokinetics (PK)...
What is the current status of trial NCT00941863?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2002-07. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00941863?
The interventions under investigation include: Sorafenib 100 mg (50-mg tablet) (DRUG), Sorafenib 200 mg (50-mg tablet) (DRUG), Sorafenib 400 mg (50-mg tablet) (DRUG), Sorafenib 400 mg (200-mg tablet) (DRUG), Sorafenib 400 mg (Expansion) (DRUG).
Who is sponsoring clinical trial NCT00941863?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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