A Phase I, Open-label, Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)
LDK378 is a novel inhibitor of ALK that is active in a broad range of ALK-activated tumor
models, including models driven by mutated versions of ALK known to be resistant to
crizotinib, and by ALK gene amplification.
The primary purpose of this study is to determine the maximum tolerated dose and/or
recommended dose for expansion in pediatric patients, and to delineate a clinical dose to be
used in any future pediatric studies. This study will also assess the safety, tolerability,
PK and preliminary evidence of antitumor activity of LDK378 in pediatric patients with
neuroblastoma, and other ALK-activated tumors.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence rate of Dose Limiting Toxicities (DLT)
cycle = within the first 21 days of patient's first dose
up to day 21 after the patient's first dose
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CLDK378X2103
NCT01742286
March 2013
September 2015
Name | Location |
---|---|
University of California at Los Angeles UCLA LeConte Location | Los Angeles, California 90095 |
Children's Healthcare of Atlanta Dept of Oncology | Atlanta, Georgia 30342 |
Dana Farber Cancer Institute Dept of Onc | Boston, Massachusetts 02115 |
Memorial Sloan Kettering Cancer Center SC - 7 | New York, New York 10021 |
Cincinnati Children's Hospital Medical Center Dept of Oncology | Cincinnati, Ohio 45229-3039 |
St. Jude's Children's Research Hospital Dept of Oncology | Memphis, Tennessee 38105-2794 |
Texas Children's Hospital Dept of Oncology | Houston, Texas 77030 |