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NCT00880308 Clinical Trial

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

Basal Cell Carcinoma Clinical Trial

Official title:
A 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 NCT00880308
Other study ID # CLDE225X2101
Secondary ID 2008-005603-26
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2009
Est. completion date July 2013

Study information
Verified date December 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 103
Est. completion date July 2013
Est. primary completion date July 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
Spain Novartis Investigative Site Barcelona Catalunya
Switzerland Novartis Investigative Site Zürich
United Kingdom Novartis Investigative Site Leicester
United States University of Pittsburgh Medical Center SC Pittsburgh Pennsylvania
United States Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Spain,  Switzerland,  United Kingdom, 

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 every other 28-day cycle
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