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NCT00046111 · ClinicalTrials.gov registry record · Phase 1

A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
1
Enrollment target

NCT00046111: Completed Phase 1 study, sponsored by GlaxoSmithKline.

NCT00046111 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00046111, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
1 participants
Enrollment target

Study Summary

The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.

Interventions

  • DRUG topotecan

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2001-09
Est. Completion 2004-04
Phase Phase 1
GlaxoSmithKline

1,345 total trials

What the finished NCT00046111 record still lists

NCT00046111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

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

NCT00046111 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00046111 about?

NCT00046111 is a clinical study titled "A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors". The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.

What is the current status of trial NCT00046111?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2001-09. Estimated completion is 2004-04.

What interventions are being tested in trial NCT00046111?

The interventions under investigation include: topotecan (DRUG).

Who is sponsoring clinical trial NCT00046111?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00046111's enrollment target sits among peer trials

1 2001st of 2000 the lowest 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 NCT00046111, the US trial registry maintained by the National Library of Medicine. NCT00046111 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.