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NCT00003207 · ClinicalTrials.gov registry record · Phase 1
Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00003207: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT00003207 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00003207, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The rationale for conducting this study lies in the premise that if indeed the reason for a limited response of Kaposi's sarcoma lesions and other advanced malignancies to chemotherapy is attributable to a high expression of P-glycoprotein, then, by inhibiting this pump, tumor kill would be enhanced and response rates as well as duration of responses would also increase. Doxil is chosen since recent studies have shown that it is superior to combination chemotherapy with ABV or BV. Doxil is also known to be active in other malignancies such as breast and ovarian cancer (34,35). PSC 833 is chosen since it has been found to reverse P-gp in vitro and in vivo, is non-immunosuppressive, and has been shown in recent Phase 1 studies to be well tolerated. There are yet no human studies reported on Doxil pharmacokinetics when combined with MDR modulators. Preclinical data shows that pharmacokinetics of Doxil, unlike free doxorubicin, is minimally affected by the addition of PSC 833 (36). Enhanced tumor toxicity was observed when PSC 833 was combined with Doxil. Since doxorubicin, the active agent in Doxil, is metabolized by the same cytochrome P450, interactions between these 2 agents may have very significant clinical implications. The purpose of this study is to assess the toxicity and determine the maximum tolerated dose of Doxil when combined with PSC 833 in the treatment of AIDS-KS and other advanced malignancies.
Primary Outcome
Each cycle is 2 weeks long and can continue until disease progression, toxicity, or patient decision
Interventions
- DRUG pegylated liposomal doxorubicin hydrochloride
- DRUG PSC 833
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 1998-03 |
| Est. Completion | 2002-07 |
| Phase | Phase 1 |
What the finished NCT00003207 record still lists
NCT00003207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which pegylated liposomal doxorubicin hydrochloride is the first listed.
NCT00003207 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00003207 about?
NCT00003207 is a clinical study titled "Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers". The rationale for conducting this study lies in the premise that if indeed the reason for a limited response of Kaposi's sarcoma lesions and other advanced malignancies to chemotherapy is attributable to a high expression of P-glycoprotein, then, by inhibiting this pump, tumor kill would be enhanced...
What is the current status of trial NCT00003207?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 1998-03. Estimated completion is 2002-07.
What interventions are being tested in trial NCT00003207?
The interventions under investigation include: pegylated liposomal doxorubicin hydrochloride (DRUG), PSC 833 (DRUG).
Who is sponsoring clinical trial NCT00003207?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00003207's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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