A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Inclusion Criteria:

• Histologically confirmed ALK-positive locally-advanced or metastatic solid tumorexcluding lung cancer
• ALK-positive tumor as per Foundation Medicine, Inc (FMI) next-generation sequencing (NGS) (NGS F1CDx, F1LCDx, or F1HEME) or per local accredited laboratory usingvalidated NGS testing of tumor tissue or peripheral blood
• No alternative effective standard therapy available, or standard therapy consideredunsuitable or intolerable to the participant
• Other cancer therapies are allowed, including investigational drugs, if anytreatment-related toxicities (excluding alopecia) have resolved to grade </= 1 or tolaboratory values as defined by the protocol
• Measurable disease at baseline as assessed by the Investigator per RECIST v1.1 or RANOcriteria (for participants with primary CNS tumors)
• Life expectancy of at least 12 weeks
• Eastern cooperative oncology group (ECOG) performance status of 0-2
• Adequate hemataologic, hepatic, and renal function
• Participants with primary central nervous system (CNS) tumors are available
• Participants with brain or leptomeningeal metastasis are allowed in the study ifasymptomatic and if they meet additional criteria as defined by the protocol
• Willingness to comply with study procedures
• Willingness to comply with home-base approach and visits by Mobile Nurses
• Ability to swallow alectinib capsules intact
• Women of childbearing potential must test negative for pregnancy at screening andprior to the first dose of study drug
• Women of childbearing potential must agree to remain abstinent or use contraceptivemethods as defined by the protocol and refrain from donating eggs during the treatmentperiod and for at least 90 days after the last dose of alectinib
• Men must agree to remain abstinent or use contraceptive methods as defined by theprotocol and refrain from donating sperm during the treatment period and for at least 90 days after the last dose of alectinib

Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
• Lung Cancer
• Patients with one of the following ALK point mutations: I1171X, G1202R, V1180L
• Prior therapy with an ALK inhibitor
• Liver disease as described in the protocol
• Known HIV, hepatitis B, or hepatitis C (HCV) infection
• Patients with symptomatic bradycardia
• Patients with symptomatic or unstable brain metastasis; patients with primary CNStumors are allowed
• Malabsorption syndrome or any other condition that would interfere with enteralabsorption
• Incomplete recovery from any surgery prior to treatment
• Any other malignancies within 5 years prior to enrollment, except for those describedin the protocol
• Any serious medical condition or abnormality in clinical laboratory tests that, in theInvestigator's judgment, precludes the patient's safe participation in and completionof the study
• History of hypersensitivity to any of the ingredients in the alectinib drugformulation