An East Asian Study of LDE225
December 16, 2020 updated by: Novartis Pharmaceuticals
An East Asian Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: LDE225
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
determine maximum tolerated dose of single agent LDE225
Time Frame: 28 day cycles
|
28 day cycles
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
characterize safety and tolerability
Time Frame: 28 day cycles
|
28 day cycles
|
|
characterize pharmacokinetics (PK) of single and repeated doses of LDE225
Time Frame: 28 day cycles
|
28 day cycles
|
|
assess preliminary anti-tumor activity
Time Frame: 28 day cycles
|
28 day cycles
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (ACTUAL)
October 1, 2013
Study Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
September 21, 2010
First Submitted That Met QC Criteria
September 23, 2010
First Posted (ESTIMATE)
September 24, 2010
Study Record Updates
Last Update Posted (ACTUAL)
December 19, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLDE225X1101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.