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NCT01208831 Clinical Trial

An East Asian Study of LDE225

Basal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01208831
Other study ID # CLDE225X1101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2010
Est. completion date October 2013

Study information
Verified date April 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LDE225

Locations
Country Name City State
Hong Kong Novartis Investigative Site Hong Kong
Japan Novartis Investigative Site Kobe-city Hyogo
Japan Novartis Investigative Site Nagoya-city Aichi
Taiwan Novartis Investigative Site Taipei

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Hong Kong,  Japan,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary determine maximum tolerated dose of single agent LDE225 28 day cycles
Secondary characterize safety and tolerability 28 day cycles
Secondary characterize pharmacokinetics (PK) of single and repeated doses of LDE225 28 day cycles
Secondary assess preliminary anti-tumor activity 28 day cycles
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