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An East Asian Study of LDE225

NCT ID: NCT01208831

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.

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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Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Kobe, Hyōgo, Japan

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Countries

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Hong Kong Japan Taiwan

References

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Minami H, Ando Y, Ma BB, Hsiang Lee J, Momota H, Fujiwara Y, Li L, Fukino K, Ito K, Tajima T, Mori A, Lin CC. Phase I, multicenter, open-label, dose-escalation study of sonidegib in Asian patients with advanced solid tumors. Cancer Sci. 2016 Oct;107(10):1477-1483. doi: 10.1111/cas.13022. Epub 2016 Sep 24.

Reference Type DERIVED
PMID: 27467121 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12324

Results for CLDE225X1101 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CLDE225X1101

Identifier Type: -

Identifier Source: org_study_id