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

NCT ID: NCT00880308

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma

Keywords

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Advanced tumors hedgehog smoothened inhibitor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LDE225

Group Type EXPERIMENTAL

LDE225

Intervention Type DRUG

Interventions

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LDE225

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* confirmed diagnosis of advanced solid tumor (including •medulloblastoma and basal cell carcinoma)
* blood work criteria

Exclusion Criteria

* patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
* positive HIV, hepatitis B or C
* impaired intestinal function
* impaired heart function
* pregnant or breast-feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of Pittsburgh Medical Center SC

Pittsburgh, Pennsylvania, United States

Site Status

Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Zurich, , Switzerland

Site Status

Novartis Investigative Site

Leicester, , United Kingdom

Site Status

Countries

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United States Spain Switzerland United Kingdom

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12203

Results for CLDE225X2101 on Novartis Clinical Trials Website

Other Identifiers

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2008-005603-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLDE225X2101

Identifier Type: -

Identifier Source: org_study_id