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

December 16, 2020 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novartis Investigative Site
  • United Kingdom
      • Leicester, United Kingdom, LE1 5WW
        • Novartis Investigative Site
  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center SC
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LDE225
Drug: LDE225

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determine maximum tolerated dose of single agent LDE225
Time Frame: 28 day cycles
28 day cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
characterize safety and tolerability
Time Frame: 28 day cycles
28 day cycles
characterize pharmacokinetics (PK) of single and repeated doses of LDE225
Time Frame: 28 day cycles
28 day cycles
assess preliminary anti-tumor activity
Time Frame: every other 28-day cycle
every other 28-day cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 9, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDE225X2101
  • 2008-005603-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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