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NCT00880308 · ClinicalTrials.gov registry record · Phase 1

Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
103
Enrollment target

NCT00880308: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.

NCT00880308 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 103 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00880308, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
103 participants
Enrollment target

Study Summary

This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.

Interventions

  • DRUG LDE225

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2009-03
Est. Completion 2013-07
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00880308 record still lists

NCT00880308 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher).

The record links to 0 conditions, and to 1 intervention - of which LDE225 is the first listed.

NCT00880308 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00880308 about?

NCT00880308 is a clinical study titled "Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors". This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.

What is the current status of trial NCT00880308?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2009-03. Estimated completion is 2013-07.

What interventions are being tested in trial NCT00880308?

The interventions under investigation include: LDE225 (DRUG).

Who is sponsoring clinical trial NCT00880308?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00880308's enrollment target sits among peer trials

103 541st of 2000 higher than 1,458 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 NCT00880308, the US trial registry maintained by the National Library of Medicine. NCT00880308 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.