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

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


Lead sponsor: Novartis Pharmaceuticals

Source Novartis
Brief 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.

Overall Status Completed
Start Date March 2009
Completion Date July 2013
Primary Completion Date July 2013
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
determine maximum tolerated dose of single agent LDE225 28 day cycles
Secondary Outcome
Measure Time Frame
characterize safety and tolerability 28 day cycles
characterize pharmacokinetics (PK) of single and repeated doses of LDE225 28 day cycles
assess preliminary anti-tumor activity every other 28-day cycle
Enrollment 103

Intervention type: Drug

Intervention name: LDE225

Arm group label: LDE225



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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals
University of Pittsburgh Medical Center SC | Pittsburgh, Pennsylvania, 15213, United States
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) | San Antonio, Texas, 78229, United States
Novartis Investigative Site | Barcelona, Catalunya, 08035, Spain
Novartis Investigative Site | Zürich, 8091, Switzerland
Novartis Investigative Site | Leicester, LE1 5WW, United Kingdom
Location Countries



United Kingdom

United States

Verification Date

December 2014

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: LDE225

Arm group type: Experimental

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov