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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00880308

Collaborator

(none)

103

Enrollment

Locations

Arm

Duration (Months)

20.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma	Drug: LDE225	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LDE225	Drug: LDE225

Arm

Intervention/Treatment

Experimental: LDE225

Drug: LDE225

Outcome Measures

Primary Outcome Measures

determine maximum tolerated dose of single agent LDE225 [28 day cycles]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center SC	Pittsburgh	Pennsylvania	United States	15213
2	Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)	San Antonio	Texas	United States	78229
3	Novartis Investigative Site	Barcelona	Catalunya	Spain	08035
4	Novartis Investigative Site	Zürich		Switzerland	8091
5	Novartis Investigative Site	Leicester		United Kingdom	LE1 5WW