Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

PHASE1CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

August 28, 2013

Primary Completion Date

April 26, 2019

Study Completion Date

April 26, 2019

Conditions
ALK-activated Tumors
Interventions
DRUG

Ceritinib

"LDK378 is a capsule taken by mouth, contents can be mixed with food for pediatric patients or mixed with water and given via nasogastric/gastric (NG/G) tube. For patients in fasted group: 1-2 tablespoons (15-30 mL) of an appropriate food such as apple sauce or non-fat yogurt and a glass of water were allowed.~For patients in the fed cohort: LDK378 was taken with, or within 30 minutes after finishing a low-fat light snack containing 100-300 calories and 1.5-2 grams of fat."

Trial Locations (23)

2130

Novartis Investigative Site, Randwick

3052

Novartis Investigative Site, Parkville

3584

Novartis Investigative Site, Utrecht

10017

Memorial Sloan Kettering SC - 7, New York

13353

Novartis Investigative Site, Berlin

20133

Novartis Investigative Site, Milan

28009

Novartis Investigative Site, Madrid

45147

Novartis Investigative Site, Essen

46026

Novartis Investigative Site, Valencia

50937

Novartis Investigative Site, Cologne

75231

Novartis Investigative Site, Paris

77030

Texas Children's Hospital Dept of Oncology, Houston

94805

Novartis Investigative Site, Villejuif

02215

Dana Farber Cancer Institute Dept of Onc, Boston

45229-3039

Cincinnati Children s Hospital Medical Center Dept of Oncology, Cincinnati

38105-2794

St Jude s Childrens Research Hospital Dept of Oncology, Memphis

M5G 1X8

Novartis Investigative Site, Toronto

1105 AZ

Novartis Investigative Site, Amsterdam

3015 CN

Novartis Investigative Site, Rotterdam

03080

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

B4 6NH

Novartis Investigative Site, West Midlands

SM2 5PT

Novartis Investigative Site, Sutton

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY