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NCT00233948 · ClinicalTrials.gov registry record · Phase 1

Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma

A Phase 1 study, sponsored by City of Hope Medical Center.

Terminated
Registry status
Phase 1
Development phase
29
Enrollment target

NCT00233948: Clinical Trial Phase 1 study, sponsored by City of Hope Medical Center.

NCT00233948 is a Phase 1 study that was terminated before completion, run by City of Hope Medical Center. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00233948, a Phase 1 study, was terminated before completion, sponsored by City of Hope Medical Center.

TERMINATED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

RATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from spreading. PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir mesylate and to see how well it works in treating patients with recurrent, metastatic, or unresectable liposarcoma.

Primary Outcome

DLT is defined as any grade III toxicity not reversible to grade II or less within one week, or any grade IV toxicity. Hyperlipidemia, hyperglycemia, nausea, vomiting and diarrhea are not DLTs unless they are uncontrolled grade 3/4. Dose delays lasting more than 2 weeks due to toxicity are considered a DLT. Dose escalation schedule for nelfinavir: 1250 mg bid ; 1500 mg bid; 2125 mg bid; 3000 mg bid; 4250 mg bid ; 6000 mg bid ; 8500 mg bid ; 12000 mg bid

Interventions

  • GENETIC gene expression analysis
  • OTHER laboratory biomarker analysis
  • PROCEDURE biopsy
  • OTHER pharmacological study
  • DRUG nelfinavir mesylate

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2006-03
Phase Phase 1
City of Hope Medical Center

582 total trials

Why NCT00233948 stopped before completion

NCT00233948 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 5 interventions - of which gene expression analysis is the first listed.

NCT00233948 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00233948 about?

NCT00233948 is a clinical study titled "Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma". RATIONALE: Antiviral drugs, such as nelfinavir mesylate, may help prevent cancer cells from spreading. PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir mesylate and to see how well it works in treating patients with recurrent, metastatic, or unresectable lipos...

What is the current status of trial NCT00233948?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2006-03.

What interventions are being tested in trial NCT00233948?

The interventions under investigation include: gene expression analysis (GENETIC), laboratory biomarker analysis (OTHER), biopsy (PROCEDURE), pharmacological study (OTHER), nelfinavir mesylate (DRUG).

Who is sponsoring clinical trial NCT00233948?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00233948's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 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 NCT00233948, the US trial registry maintained by the National Library of Medicine. NCT00233948 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.