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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 is a Phase 1 study that has completed, run by Oncology Specialists, S.C.. The registered enrollment target is 17 participants.
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.
Interventions
- DRUG Gleevec + Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-01 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00424385
The ClinicalTrials.gov registry entry for NCT00424385 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oncology Specialists, S.C., which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gleevec + Sorafenib is the first listed.
NCT00424385 reports 0 study locations.
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.
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