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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: Completed Phase 1 study, sponsored by Bayer.
NCT00941863 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 158 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (163% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria (CTC) Grade 4 Neutropenia in specific conditions, platelets \< 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any
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 |
What the finished NCT00941863 record still lists
NCT00941863 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (163% higher).
The record links to 0 conditions, and to 5 interventions - of which Sorafenib 100 mg (50-mg tablet) is the first listed.
NCT00941863 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00941863's enrollment target sits among peer trials
158 348th of 2000 higher than 1,650 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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