A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase

Completed · Phase 1

Conditions studied: Tumors Characterized by Genetic Abnormalities of ALK

In brief

This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).

Key facts

Study ID

NCT01283516

Run by

Novartis Pharmaceuticals

People needed

304

Starts

2011-01-24

Expected to finish

2016-05-03

Last updated by the study team

2019-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG Performance Status of ≤ 2 and life expectancy of ≥ 12 weeks.
• Diagnosed with a locally advanced or metastatic malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists. Only patients with tumors characterized by genetic abnormalities in ALK were enrolled.
• For NSCLC, an ALK translocation must be detected by FISH in ≥ 15% of tumor cells.
• In patients with diseases other than NSCLC, ALK translocation is not required and overexpression of ALK protein may be considered indicative of a genetic abnormality in ALK.
• Patients with measurable or non-measurable disease as determined by modified RECIST version 1.0 in dose-escalation phase, and patients with at least one measurable lesion as determined by RECIST 1.0 in expansion phase.

You may not qualify if…

• Patients with symptomatic central nervous system (CNS) metastases who were neurologically unstable or required increasing doses of steroids to control their CNS disease were excluded.
• Patients with a prior or current history of a second malignancy, impaired GI function, history of pancreatitis or increased amylase or lipase, known diagnosis of HIV, and clinically significant cardiac disease were excluded.
• Patients treated with chemotherapy or biologic therapy or other investigational agent < 2 weeks prior to starting study drug for compounds with a half-life ≤ 3 days, and < 4 weeks prior to starting study drug for compounds with a prolonged half-life were excluded.
• Further, patients treated with medications that were known to be strong inhibitors or inducers of CYP3A4/5 that could not be discontinued at least a week prior to start of treatment with LDK378 and for the duration of the study were also excluded.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of Colorado School of Medicine Colorado Univ — Aurora, Colorado, United States
• Massachusetts General Hospital Mass General — Boston, Massachusetts, United States
• Memorial Sloan Kettering MSK — New York, New York, United States
• Fox Chase Cancer Center Fox Chase Cancer (2) — Philadelphia, Pennsylvania, United States
• University of Utah / Huntsman Cancer Institute Huntsman — Salt Lake City, Utah, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Rozzano, MI, Italy
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Glasgow, Scotland, United Kingdom
• Novartis Investigative Site — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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