A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges

PHASE2CompletedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

April 1, 2015

Primary Completion Date

February 6, 2019

Study Completion Date

February 6, 2019

Conditions
ALK-positive Non-small Cell Lung Cancer
Interventions
DRUG

Ceritinib

LDK378 is a gelatin capsule, administered orally once daily at a dose of 750 mg (five 150 mg capsules) on a continuous dosing schedule on an empty stomach.

Trial Locations (57)

3000

Novartis Investigative Site, Leuven

10002

Novartis Investigative Site, Taipei

10043

Novartis Investigative Site, Orbassano

11217

Novartis Investigative Site, Taipei

13915

Novartis Investigative Site, Marseille

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

20900

Novartis Investigative Site, Monza

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28222

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

33081

Novartis Investigative Site, Aviano

34098

Novartis Investigative Site, Istanbul

35043

Novartis Investigative Site, Rennes

37126

Novartis Investigative Site, Verona

43100

Novartis Investigative Site, Parma

43221

The Ohio State University Comprehensive Cancer Center Ohio State University, Columbus

44805

Novartis Investigative Site, Saint-Herblain Cédex

46601

Memorial Hospital of South Bend, South Bend

50937

Novartis Investigative Site, Cologne

57124

Novartis Investigative Site, Livorno

67091

Novartis Investigative Site, Strasbourg

70403

Novartis Investigative Site, Tainan City

74133

Southwestern Regional Medical Center, Tulsa

75970

Novartis Investigative Site, Paris

80131

Novartis Investigative Site, Napoli

90033

USC Kenneth Norris Comprehensive Cancer Center SC-3, Los Angeles

94304

Stanford Universtiy Medical Center SC-5, Stanford

94805

Novartis Investigative Site, Villejuif

98105

Seattle Cancer Care Alliance, Seattle

98158

Novartis Investigative Site, Messina

99437

Novartis Investigative Site, Bad Berka

169610

Novartis Investigative Site, Singapore

192148

Novartis Investigative Site, Saint Petersburg

02215

Dana Farber Cancer Institute SC-12, Boston

Unknown

Novartis Investigative Site, Auckland

Novartis Investigative Site, Pokfulam

41253-190

Novartis Investigative Site, Salvador

59075 740

Novartis Investigative Site, Natal

90610-000

Novartis Investigative Site, Porto Alegre

88301-229

Novartis Investigative Site, Itajaí

14784 400

Novartis Investigative Site, Barretos

01246 000

Novartis Investigative Site, São Paulo

01236 030

Novartis Investigative Site, São Paulo

M5G 2M9

Novartis Investigative Site, Toronto

06129

Novartis Investigative Site, Perugia

00155

Novartis Investigative Site, Roma

1066 CX

NKI-AVL, Department of Thoracic-Oncology, Amsterdam

05505

Novartis Investigative Site, Seoul

03080

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08041

Novartis Investigative Site, Barcelona

06100

Novartis Investigative Site, Ankara

SM2 5PT

Novartis Investigative Site, Sutton

B9 5SS

Novartis Investigative Site, Birmingham

SE1 9RT

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY