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

Completed · Phase 1

Conditions studied: ALK-activated Tumors

In brief

The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.

Key facts

Study ID

NCT01742286

Run by

Novartis Pharmaceuticals

People needed

83

Starts

2013-08-28

Expected to finish

2019-04-26

Last updated by the study team

2020-06-09

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
• Age ≥ 12 months and < 18 years
• The tumor must carry a genetic alteration of ALK
• Patients must have evaluable or measurable disease.
• Karnofsky performance status score ≥ 60% for patients > 12 years of age; Lansky score ≥ 50% for patients ≤ 12 years of age.

You may not qualify if…

• Symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy (such as radiotherapy, surgery or intrathecal chemotherapy) to control their CNS disease
• Inadequate end organ function as defined by specified laboratory values
• Body surface area (BSA) < 0.35 m2
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LDK378 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
• Use of medications that are known to be strong inhibitors or inducers of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
• Use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment with LDK378 and for the duration of the study
• History of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
• History of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
• Medications with a known risk of prolongation of QT interval

Where it is running

• Dana Farber Cancer Institute Dept of Onc — Boston, Massachusetts, United States
• Memorial Sloan Kettering SC - 7 — New York, New York, United States
• Cincinnati Children s Hospital Medical Center Dept of Oncology — Cincinnati, Ohio, United States
• St Jude s Childrens Research Hospital Dept of Oncology — Memphis, Tennessee, United States
• Texas Children's Hospital Dept of Oncology — Houston, Texas, United States
• Novartis Investigative Site — Randwick, New South Wales, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Utrecht, CS, Netherlands
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Rotterdam, Netherlands
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Valencia, Valencia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — West Midlands, Birmingham, United Kingdom
• Novartis Investigative Site — Sutton, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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