Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors

Novartis Pharmaceuticals103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

103

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 (5)

University of Pittsburgh Medical Center SC

Pittsburgh, Pennsylvania, United States

Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)

San Antonio, Texas, United States

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

Zurich, Switzerland

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: every other 28-day cycle

Data from ClinicalTrials.gov

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