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An East Asian Study of LDE225

Primary Purpose

Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

LDE225

About this trial

This is an interventional treatment trial for Advanced Solid Tumor Cancers focused on measuring Advanced tumors, hedgehog, smoothened inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDE225

Arm Description

Outcomes

Primary Outcome Measures

determine maximum tolerated dose of single agent LDE225

Secondary Outcome Measures

characterize safety and tolerability

characterize pharmacokinetics (PK) of single and repeated doses of LDE225

assess preliminary anti-tumor activity

Full Information

NCT ID

NCT01208831

First Posted

September 21, 2010

Last Updated

December 16, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01208831

Brief Title

An East Asian Study of LDE225

Official Title

An East Asian Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma

Keywords

Advanced tumors, hedgehog, smoothened inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDE225

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

LDE225

Primary Outcome Measure Information:

Title

determine maximum tolerated dose of single agent LDE225

Time Frame

28 day cycles

Secondary Outcome Measure Information:

Title

characterize safety and tolerability

Time Frame

28 day cycles

Title

characterize pharmacokinetics (PK) of single and repeated doses of LDE225

Time Frame

28 day cycles

Title

assess preliminary anti-tumor activity

Time Frame

28 day cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Hong Kong

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Nagoya-city

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Kobe-city

State/Province

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

27467121

Citation

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.

Results Reference

derived

Links:

URL

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

Description

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

Learn more about this trial

An East Asian Study of LDE225

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