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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00880308
First received: April 9, 2009
Last updated: August 11, 2014
Last verified: August 2014

April 9, 2009
August 11, 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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: every other 28-day cycle ] [ Designated as safety issue: No ]
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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   Switzerland,   United Kingdom
 
NCT00880308
CLDE225X2101, 2008-005603-26
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2014

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