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
  Purpose

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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • determine maximum tolerated dose of single agent LDE225 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 103
Study Start Date: March 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDE225 Drug: LDE225

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00880308     History of Changes
Other Study ID Numbers: CLDE225X2101, 2008-005603-26
Study First Received: April 9, 2009
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic

Keywords provided by Novartis:
Advanced tumors
hedgehog
smoothened inhibitor

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Medulloblastoma
Neoplasms
Carcinoma
Glioma
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive

ClinicalTrials.gov processed this record on October 30, 2014