Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)

Exclusion Criteria

• •Patients with symptomatic Central Nerve System (CNS) metastases who are neurologically unstable or require increasing doses of steroids to control their CNS disease
• •Patients with unresolved nausea, vomiting or diarrhea \> Common Terminology Criteria for Adverse Events (CTCAE) grade 1
• •Other concurrent severe and/or uncontrolled medical conditions
• •Patients who have been treated with chemotherapy or biologic therapy or other investigational agent \< 2 weeks prior to starting the daily dosing of the study drug for compounds with a half-life ≤ 3 days, and \< 4 weeks prior to starting the daily dosing of the study drug for compounds with a prolonged half-life (\< 6 weeks for patients that received nitrosoureas or mitomycin-C)
• •Unresolved toxicity greater than CTCAE grade 1 or unstable toxicity from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia), or incomplete recovery from previous surgery, unless agreed by Novartis and the Principal Investigator and documented
• •Patients who have received radiotherapy to lung within 4 weeks prior to starting the daily dosing of the study drug or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites radiotherapy to a large volume (including whole brain radiotherapy) \< 2 weeks prior to starting the daily dosing of the study drug, and patients who have received radiotherapy to a small volume (including stereotactic radiotherapy to the CNS) \< 3 days prior to starting the study drug.