An East Asian Study of LDE225
An East Asian Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
1 other identifier
interventional
45
3 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2010
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2010
CompletedFirst Posted
Study publicly available on registry
September 24, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedDecember 19, 2020
April 1, 2016
3 years
September 21, 2010
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
determine maximum tolerated dose of single agent LDE225
28 day cycles
Secondary Outcomes (3)
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
Study Arms (1)
LDE225
EXPERIMENTALInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8560, Japan
Novartis Investigative Site
Kobe, Hyōgo, 650-0017, Japan
Novartis Investigative Site
Taipei, 10048, Taiwan
Related Publications (1)
Minami H, Ando Y, Ma BB, Hsiang Lee J, Momota H, Fujiwara Y, Li L, Fukino K, Ito K, Tajima T, Mori A, Lin CC. Phase I, multicenter, open-label, dose-escalation study of sonidegib in Asian patients with advanced solid tumors. Cancer Sci. 2016 Oct;107(10):1477-1483. doi: 10.1111/cas.13022. Epub 2016 Sep 24.
PMID: 27467121DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2010
First Posted
September 24, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
December 19, 2020
Record last verified: 2016-04