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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma |
Drug: LDE225 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- determine maximum tolerated dose of single agent LDE225 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- characterize safety and tolerability [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
- characterize pharmacokinetics (PK) of single and repeated doses of LDE225 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
- assess preliminary anti-tumor activity [ Time Frame: 28 day cycles ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LDE225 | Drug: LDE225 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208831
Contacts
| Contact: Novartis Pharmaceuticals | +41613241111 | |
| Contact: Novartis Pharmaceuticals | +1 800 340 6843 ext +81337978748 |
Locations
| Hong Kong | |
| Novartis Investigative Site | Completed |
| Hong Kong, Hong Kong | |
| Japan | |
| Novartis Investigative Site | Completed |
| Nagoya, Aichi, Japan, 466-8560 | |
| Novartis Investigative Site | Completed |
| Kobe, Hyogo, Japan, 650-0017 | |
| Taiwan | |
| Novartis Investigative Site | Recruiting |
| Taipei, Taiwan, 10048 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01208831 History of Changes |
| Other Study ID Numbers: | CLDE225X1101 |
| Study First Received: | September 21, 2010 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Food and Drug Administration Japan: Pharmaceuticals and Medical Devices Agency Hong Kong: Department of Health Taiwan: Taiwan Floriculture Development Association |
Keywords provided by Novartis:
|
Advanced tumors hedgehog smoothened inhibitor |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Basal Cell Medulloblastoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell |
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroectodermal Tumors, Primitive Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 23, 2013