An East Asian Study of LDE225
This study is currently recruiting participants.
Verified April 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01208831
First received: September 21, 2010
Last updated: April 16, 2013
Last verified: April 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 21, 2010 | ||||||||
| Last Updated Date | April 16, 2013 | ||||||||
| Start Date ICMJE | October 2010 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
determine maximum tolerated dose of single agent LDE225 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01208831 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | An East Asian Study of LDE225 | ||||||||
| Official Title ICMJE | An East Asian Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: LDE225 | ||||||||
| Study Arm (s) | Experimental: LDE225
Intervention: Drug: LDE225 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 44 | ||||||||
| Estimated Completion Date | September 2013 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Hong Kong, Japan, Taiwan | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01208831 | ||||||||
| Other Study ID Numbers ICMJE | CLDE225X1101 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Novartis ( Novartis Pharmaceuticals ) | ||||||||
| Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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