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

Completed · Phase 1

Conditions studied: Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00880308

Run by

Novartis Pharmaceuticals

People needed

103

Starts

2009-03-01

Expected to finish

2013-07-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center SC — Pittsburgh, Pennsylvania, United States
• Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) — San Antonio, Texas, United States
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Zurich, Switzerland
• Novartis Investigative Site — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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