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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.

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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

FieldValue
Enrollment Target 52 participants
Start Date 1994-03
Est. Completion 2001-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.