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An East Asian Study of LDE225

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01208831
First received: September 21, 2010
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.


Condition Intervention Phase
Advanced Solid Tumor Cancers
Medulloblastoma
Basal Cell Carcinoma
Drug: LDE225
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An East Asian 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: 28 day cycles ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: October 2010
Study Completion Date: October 2013
Primary Completion Date: October 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: NCT01208831

Locations
Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site
Kobe-city, Hyogo, Japan, 650-0017
Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10048
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01208831     History of Changes
Other Study ID Numbers: CLDE225X1101
Study First Received: September 21, 2010
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Hong Kong: Department of Health
Taiwan: Taiwan Floriculture Development Association

Keywords provided by Novartis:
Advanced tumors
hedgehog
smoothened inhibitor

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Medulloblastoma
Carcinoma
Glioma
Neoplasms
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 November 23, 2014