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Completed

NCT Number: NCT01208831

An East Asian Study of LDE225

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.

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Key information

Conditions

Advanced Solid Tumor Cancers Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Glioma Medulloblastoma 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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LDE225

Drug

Primary outcomes

  1. determine maximum tolerated dose of single agent LDE225

    Time frame: 28 day cycles

Secondary outcomes

  1. characterize safety and tolerability

    Time frame: 28 day cycles

  2. characterize pharmacokinetics (PK) of single and repeated doses of LDE225

    Time frame: 28 day cycles

  3. assess preliminary anti-tumor activity

    Time frame: 28 day cycles

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 24, 2010
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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