A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

PHASE2CompletedINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

June 29, 2011

Primary Completion Date

June 28, 2013

Study Completion Date

June 29, 2018

Conditions
Basal Cell Carcinoma
Interventions
DRUG

LDE225

LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.

Trial Locations (62)

1200

Novartis Investigative Site, Brussels

1211

Novartis Investigative Site, Geneva

2065

Novartis Investigative Site, St Leonards

2610

Novartis Investigative Site, Wilrijk

3010

Novartis Investigative Site, Bern

3220

Novartis Investigative Site, Geelong

4032

Novartis Investigative Site, Debrecen

8091

Novartis Investigative Site, Zurich

10016

New York University Medical Center SC-2, New York

10126

Novartis Investigative Site, Torino

13353

Novartis Investigative Site, Berlin

13885

Novartis Investigative Site, Marseille

15213

University of Pittsburgh Medical Center UPMC, Pittsburgh

20010

Washington Hospital Center Wash Hospital, Washington D.C.

21682

Novartis Investigative Site, Stade

24105

Novartis Investigative Site, Kiel

28034

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

30625

Novartis Investigative Site, Hanover

31059

Novartis Investigative Site, Toulouse

33612

H Lee Moffitt Cancer Center and Research Institute Cutaneous Onc Dept, Tampa

45147

Novartis Investigative Site, Essen

48157

Novartis Investigative Site, Münster

55131

Novartis Investigative Site, Mainz

60611

NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Study coordinator, Chicago

63110

Washington University School Of Medicine-Siteman Cancer Ctr Siteman, St Louis

69373

Novartis Investigative Site, Lyon

69495

Novartis Investigative Site, Pierre-Bénite

72703

Highlands Oncology Group, Fayetteville

75246

Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology, Dallas

Texas Oncology Tex Onc 3, Dallas

Texas Oncology Texas Onc - Amarillo, Dallas

76310

Texoma Cancer Center Texoma Cancer Center, Wichita Falls

76712

Texas Oncology Cancer Care & Research Center, Waco

77030

University of Texas MD Anderson Cancer Center MD Anderson, Houston

79106

Novartis Investigative Site, Freiburg im Breisgau

80045

University of Colorado School of Medicine UC, Aurora

80131

Novartis Investigative Site, Napoli

81377

Novartis Investigative Site, München

84103

University of Utah / Huntsman Cancer Institute Huntsman/Univ UT, Salt Lake City

89109

Comprehensive Cancer Centers of Nevada CCC of Nevada- Southwest (2), Las Vegas

90095

University of California at Los Angeles UCLA 3, Los Angeles

94304

Stanford University Medical Center Stanford Univ 2, Stanford

94805

Novartis Investigative Site, Villejuif

02215

Dana Farber Cancer Institute DFCI - MA, Boston

48202 2689

Henry Ford Hospital Henry Ford, Detroit

07601

Hackensack University Medical Center Hackensack (SC), Hackensack

17033-085

Penn State University / Milton S. Hershey Medical Center Hershey Medical, Hershey

N2J 1C4

Novartis Investigative Site, Waterloo

G1V 4T3

Novartis Investigative Site, Sainte-Foy

07548

Novartis Investigative Site, Gera

161 21

Novartis Investigative Site, Athens

H-1085

Novartis Investigative Site, Budapest

H-6725

Novartis Investigative Site, Szeged

08035

Novartis Investigative Site, Barcelona

NE7 7DN

Novartis Investigative Site, High Heaton

BA21 4AT

Novartis Investigative Site, Yeovil

CF14 4XW

Novartis Investigative Site, Cardiff

G3 8SJ

Novartis Investigative Site, Glasgow

LE1 5WW

Novartis Investigative Site, Leicester

EC1A 7BE

Novartis Investigative Site, London

M13 9WL

Novartis Investigative Site, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY