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

This study is currently recruiting participants.

Verified by Novartis, April 2009

First Received: April 9, 2009 Last Updated: April 10, 2009 History of Changes

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
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 I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
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:	58
Study Start Date:	March 2009
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
LDE225: Experimental	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

Contacts

Contact: Novartis Pharmaceuticals

+1-800-340-6843

Locations

United States, Pennsylvania
University of Pittsburg Medical Center	Recruiting
Pittsburg, Pennsylvania, United States, 15232
Contact: Mara Yerk 412-623-5198
Principal Investigator: Hussein Tawbi, M.D.
United States, Texas
Cancer Therapy and Research Center	Recruiting
San Antonio, Texas, United States, 78229
Contact: Pat O'Rourke, MSA 210-450-5976
Principal Investigator: Alain Mita, M.D.

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLDE225X2101, EudraCT 2008-005603-26
Study First Received:	April 9, 2009
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00880308 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

Advanced tumors

Study placed in the following topic categories:

Neuroectodermal Tumors
Signs and Symptoms
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Medulloblastoma
Neuroepithelioma

Neoplasms, Basal Cell
Carcinoma, Basal Cell
Glioma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Nerve Tissue
Carcinoma, Basal Cell
Carcinoma
Neuroectodermal Tumors
Neoplasms

Neoplasms, Germ Cell and Embryonal
Medulloblastoma
Neoplasms, Basal Cell
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 04, 2009