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NCT00424385 · ClinicalTrials.gov registry record · Phase 1
Study Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-independent Prostate Cancer (AIPC)
A Phase 1 study, sponsored by Oncology Specialists, S.C..
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00424385: Completed Phase 1 study, sponsored by Oncology Specialists, S.C..
NCT00424385 is a Phase 1 study that has completed, run by Oncology Specialists, S.C.. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00424385, a Phase 1 study, has completed, sponsored by Oncology Specialists, S.C..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3 patients to be on study. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. Once the pre-specified 400 mg by mouth two times a day (PO BID) dosing for both drugs is reached without toxicity, the study will close for accrual. If toxicity is noted prior to reaching the 400 mg PO BID dosing, then the dosing schedule that is deemed safest as per study design will be the one used for any future phase II study.
Primary Outcome
Eligible patients were enrolled in one of 4 cohorts, where each cohort allowed 3 evaluable patients to be on study, patients withdrawn from treatment for reasons other than toxicity were not considered evaluable. If one of the three evaluable patients experienced a dose limiting toxicity (DLT) the cohort was expanded to 6 evaluable patients. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established.
Interventions
- DRUG Gleevec + Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
What the finished NCT00424385 record still lists
NCT00424385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Gleevec + Sorafenib is the first listed.
NCT00424385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00424385 about?
NCT00424385 is a clinical study titled "Study Combining Imatinib Mesylate (Gleevec) With Sorafenib in Patients With Androgen-independent Prostate Cancer (AIPC)". Eligible patients will be enrolled in one of 4 cohorts where each cohort will allow 3 patients to be on study. Patients will receive both study drugs on escalated dosing schedule until the maximum of 400 mg PO BID is reached for both drugs or toxicity is established. Once the pre-specified 400 mg by...
What is the current status of trial NCT00424385?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2007-01. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00424385?
The interventions under investigation include: Gleevec + Sorafenib (DRUG).
Who is sponsoring clinical trial NCT00424385?
This trial is sponsored by Oncology Specialists, S.C., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00424385's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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