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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880308
First Posted: April 13, 2009
Last Update Posted: December 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
April 9, 2009
April 13, 2009
December 30, 2014
March 2009
July 2013   (Final data collection date for primary outcome measure)
determine maximum tolerated dose of single agent LDE225 [ Time Frame: 28 day cycles ]
Same as current
Complete list of historical versions of study NCT00880308 on ClinicalTrials.gov Archive Site
  • characterize safety and tolerability [ Time Frame: 28 day cycles ]
  • characterize pharmacokinetics (PK) of single and repeated doses of LDE225 [ Time Frame: 28 day cycles ]
  • assess preliminary anti-tumor activity [ Time Frame: every other 28-day cycle ]
Same as current
Not Provided
Not Provided
 
Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors
A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced Solid Tumor Cancers
  • Medulloblastoma
  • Basal Cell Carcinoma
Drug: LDE225
Experimental: LDE225
Intervention: Drug: LDE225
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
July 2013
July 2013   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain,   Switzerland,   United Kingdom,   United States
 
 
NCT00880308
CLDE225X2101
2008-005603-26 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP