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

Primary Purpose

Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

LDE225

About this trial

This is an interventional treatment trial for Advanced Solid Tumor Cancers focused on measuring Advanced tumors, hedgehog, smoothened inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Pittsburgh Medical Center SC
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDE225

Arm Description

Outcomes

Primary Outcome Measures

determine maximum tolerated dose of single agent LDE225

Secondary Outcome Measures

characterize safety and tolerability

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

assess preliminary anti-tumor activity

Full Information

NCT ID

NCT00880308

First Posted

April 9, 2009

Last Updated

December 16, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00880308

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma

Keywords

Advanced tumors, hedgehog, smoothened inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDE225

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

LDE225

Primary Outcome Measure Information:

Title

determine maximum tolerated dose of single agent LDE225

Time Frame

28 day cycles

Secondary Outcome Measure Information:

Title

characterize safety and tolerability

Time Frame

28 day cycles

Title

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

Time Frame

28 day cycles

Title

assess preliminary anti-tumor activity

Time Frame

every other 28-day cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

University of Pittsburgh Medical Center SC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

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

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=12203

Description

Results for CLDE225X2101 on Novartis Clinical Trials Website

Learn more about this trial

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

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