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NCT00001383 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT00001383: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001383 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001383, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, then beginning 3 days prior to paclitaxel on subsequent courses. Stable and responding patients are re-treated every 21 days, with paclitaxel dose adjusted to maintain an absolute neutrophil count less than 500 for no more than 4 days.
Interventions
- DRUG paclitaxel
- DRUG PSC 833
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 1994-03 |
| Est. Completion | 2001-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001383
The ClinicalTrials.gov registry entry for NCT00001383 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which paclitaxel is the first listed.
NCT00001383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001383 about?
NCT00001383 is a clinical study titled "A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833". This is a dosage escalation study to estimate the maximum tolerated dose of drug resistance inhibitor PSC 833 given in combination with paclitaxel. Groups of 3 to 6 patients receive continuous-infusion paclitaxel for 5 days and oral PSC 833 for 6-7 days, following paclitaxel on the first course, the...
What is the current status of trial NCT00001383?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 1994-03. Estimated completion is 2001-01.
What interventions are being tested in trial NCT00001383?
The interventions under investigation include: paclitaxel (DRUG), PSC 833 (DRUG).
Who is sponsoring clinical trial NCT00001383?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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