An East Asian Study of LDE225

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01208831

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

11.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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 :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 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 [28 day cycles]

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	Novartis Investigative Site	Hong Kong		Hong Kong
2	Novartis Investigative Site	Nagoya-city	Aichi	Japan	466-8560
3	Novartis Investigative Site	Kobe-city	Hyogo	Japan	650-0017
4	Novartis Investigative Site	Taipei		Taiwan	10048