CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed
Drug / intervention
PSC 833 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00001383
NCT00001383Phase 1Completed

A Phase I Study of Infusional Paclitaxel With the P-Glycoprotein Antagonist PSC 833

National Cancer Institute (NCI)·interventional·Posted Dec 10, 2002·Updated Mar 4, 2008

In Brief

A Phase 1 clinical trial evaluating PSC 833 and paclitaxel for Breast Cancer and 4 related conditions. Completed, across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 10, 2002
Enrollment StartMar 1, 1994
Study CompletionJan 1, 2001
TodayJul 2, 2026
Posted 23.6 years ago

Interventions

PSC 833drug

paclitaxeldrug