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NCT00001302 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833
A Phase 1 study of Breast Cancer and Ovarian Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT00001302 is a Phase 1 study of Breast Cancer and Ovarian Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 80 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001302, a Phase 1 study of Breast Cancer and Ovarian Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.
Conditions Studied
Interventions
- DRUG PSC 833
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 1992-09 |
| Est. Completion | 2002-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001302
The ClinicalTrials.gov registry entry for NCT00001302 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which PSC 833 is the first listed.
NCT00001302 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001302 about?
NCT00001302 is a clinical study titled "A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833". The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunos...
What is the current status of trial NCT00001302?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 1992-09. Estimated completion is 2002-06.
What conditions does trial NCT00001302 study?
This clinical trial studies the following conditions: Breast Cancer, Ovarian Cancer, Lymphoma, Neoplasm Metastasis, Kidney Neoplasm.
What interventions are being tested in trial NCT00001302?
The interventions under investigation include: PSC 833 (DRUG).
Who is sponsoring clinical trial NCT00001302?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001302 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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