NCT00880308

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_1

Geographic Reach
4 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

April 9, 2009

Last Update Submit

December 16, 2020

Conditions

Advanced Solid Tumor CancersMedulloblastomaBasal Cell Carcinoma

Keywords

Advanced tumorshedgehogsmoothened inhibitor

Outcome Measures

Primary Outcomes (1)

  • determine maximum tolerated dose of single agent LDE225

    28 day cycles

Secondary Outcomes (3)

  • characterize safety and tolerability

    28 day cycles

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

    28 day cycles

  • assess preliminary anti-tumor activity

    every other 28-day cycle

Study Arms (1)

LDE225

EXPERIMENTAL
Drug: LDE225

Interventions

LDE225DRUG
LDE225

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed diagnosis of advanced solid tumor (including •medulloblastoma and basal cell carcinoma)
  • blood work criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Pittsburgh Medical Center SC

Pittsburgh, Pennsylvania, 15213, United States

Location

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

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Leicester, LE1 5WW, United Kingdom

Location

Related Links

MeSH Terms

Conditions

MedulloblastomaCarcinoma, Basal Cell

Interventions

sonidegib

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaNeoplasms, Basal Cell

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 13, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 19, 2020

Record last verified: 2014-12

Locations

GB(1)ES(1)US(2)CH(1)