An East Asian Study of LDE225

Phase 1CompletedNCT01208831

Novartis Pharmaceuticals45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma

Interventions

LDE225DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Novartis Investigative Site

Hong Kong, Hong Kong

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Taipei, Taiwan

Outcomes

Primary Outcomes

determine maximum tolerated dose of single agent LDE225

Time frame: 28 day cycles

Secondary Outcomes

characterize safety and tolerability

Time frame: 28 day cycles

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

Time frame: 28 day cycles

assess preliminary anti-tumor activity

Time frame: 28 day cycles

Data from ClinicalTrials.gov

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