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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00880308 |
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.
Condition | Intervention | Phase |
---|---|---|
Advanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma |
Drug: LDE225 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase I, Multicenter, Open-Label, Dose-Escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 58 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
LDE225: Experimental | Drug: LDE225 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis Pharmaceuticals | +1-800-340-6843 |
United States, Pennsylvania | |
University of Pittsburg Medical Center | Recruiting |
Pittsburg, Pennsylvania, United States, 15232 | |
Contact: Mara Yerk 412-623-5198 | |
Principal Investigator: Hussein Tawbi, M.D. | |
United States, Texas | |
Cancer Therapy and Research Center | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Pat O'Rourke, MSA 210-450-5976 | |
Principal Investigator: Alain Mita, M.D. |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CLDE225X2101, EudraCT 2008-005603-26 |
Study First Received: | April 9, 2009 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00880308 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines |
Advanced tumors |
Neuroectodermal Tumors Signs and Symptoms Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Medulloblastoma Neuroepithelioma |
Neoplasms, Basal Cell Carcinoma, Basal Cell Glioma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive Neoplasms, Nerve Tissue Carcinoma, Basal Cell Carcinoma Neuroectodermal Tumors Neoplasms |
Neoplasms, Germ Cell and Embryonal Medulloblastoma Neoplasms, Basal Cell Glioma Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |