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A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma

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Trial Information

A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

determine maximum tolerated dose of single agent LDE225

Outcome Time Frame:

28 day cycles

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLDE225X2101

NCT ID:

NCT00880308

Start Date:

March 2009

Completion Date:

December 2013

Related Keywords:

  • Advanced Solid Tumor Cancers
  • Medulloblastoma
  • Basal Cell Carcinoma
  • Advanced tumors
  • hedgehog
  • smoothened inhibitor
  • Carcinoma
  • Carcinoma, Basal Cell
  • Medulloblastoma
  • Neoplasms

Name

Location

University of Pittsburgh Medical Center SCPittsburgh, Pennsylvania  
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)San Antonio, Texas  78229