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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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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
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001383 record still lists

NCT00001383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).

The record links to 0 conditions, and to 2 interventions - of which paclitaxel is the first listed.

NCT00001383 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00001383's enrollment target sits among peer trials

52 956th of 2000 higher than 1,032 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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Source: ClinicalTrials.gov NCT00001383, the US trial registry maintained by the National Library of Medicine. NCT00001383 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.