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Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT00880308
Recruitment Status : Completed
First Posted : April 13, 2009
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma Drug: LDE225 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
Study Start Date : March 2009
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sonidegib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: LDE225 Drug: LDE225



Primary Outcome Measures :
  1. determine maximum tolerated dose of single agent LDE225 [ Time Frame: 28 day cycles ]

Secondary Outcome Measures :
  1. characterize safety and tolerability [ Time Frame: 28 day cycles ]
  2. characterize pharmacokinetics (PK) of single and repeated doses of LDE225 [ Time Frame: 28 day cycles ]
  3. assess preliminary anti-tumor activity [ Time Frame: every other 28-day cycle ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880308


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center SC
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
San Antonio, Texas, United States, 78229
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Switzerland
Novartis Investigative Site
Zürich, Switzerland, 8091
United Kingdom
Novartis Investigative Site
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00880308     History of Changes
Other Study ID Numbers: CLDE225X2101
2008-005603-26 ( EudraCT Number )
First Posted: April 13, 2009    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced tumors
hedgehog
smoothened inhibitor

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Medulloblastoma
Carcinoma
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