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NCT00016354 · ClinicalTrials.gov registry record · Phase 1

Benzoylphenylurea in Treating Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target

NCT00016354: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT00016354 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00016354, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients who have advanced solid tumors.

Primary Outcome

Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays \>2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting \<5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.

Interventions

  • DRUG benzoylphenylurea

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2001-03
Est. Completion 2006-09
Phase Phase 1

What the finished NCT00016354 record still lists

NCT00016354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).

The record links to 0 conditions, and to 1 intervention - of which benzoylphenylurea is the first listed.

NCT00016354 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00016354 about?

NCT00016354 is a clinical study titled "Benzoylphenylurea in Treating Patients With Advanced Solid Tumors". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients who have advanced solid tumors.

What is the current status of trial NCT00016354?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2001-03. Estimated completion is 2006-09.

What interventions are being tested in trial NCT00016354?

The interventions under investigation include: benzoylphenylurea (DRUG).

Who is sponsoring clinical trial NCT00016354?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00016354's enrollment target sits among peer trials

19 1716th of 2000 higher than 281 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 NCT00016354, the US trial registry maintained by the National Library of Medicine. NCT00016354 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.