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

This study is ongoing, but not recruiting participants.

First Received on April 9, 2009. Last Updated on May 18, 2012 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00880308

Purpose

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.

Condition	Intervention	Phase
Advanced Solid Tumor Cancers Medulloblastoma Basal Cell Carcinoma	Drug: LDE225	Phase 1

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LDE225 in Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

determine maximum tolerated dose of single agent LDE225 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

characterize safety and tolerability [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
characterize pharmacokinetics (PK) of single and repeated doses of LDE225 [ Time Frame: 28 day cycles ] [ Designated as safety issue: Yes ]
assess preliminary anti-tumor activity [ Time Frame: every other 28-day cycle ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LDE225	Drug: LDE225

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880308

Locations

United States, Pennsylvania
University of Pittsburg Medical Center
Pittsburg, Pennsylvania, United States, 15232
United States, Texas
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Spain
Novartis Investigative Site
Planta Baja, Spain
Switzerland
Novartis Investigative Site
Zurich, Switzerland
United Kingdom
Novartis Investigative Site
Leicester, United Kingdom

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00880308 History of Changes
Other Study ID Numbers:	CLDE225X2101, EudraCT 2008-005603-26
Study First Received:	April 9, 2009
Last Updated:	May 18, 2012
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Spanish Agency of Medicines CH: Swiss HA

Keywords provided by Novartis:

Advanced tumors
hedgehog
smoothened inhibitor

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Basal Cell
Medulloblastoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell

Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroectodermal Tumors, Primitive
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 23, 2012