Breast Cancer Clinical Trial
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.
Histologically confirmed ALK-positive locally-advanced or metastatic solid tumor excluding 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 using validated NGS testing of tumor tissue or peripheral blood
No alternative effective standard therapy available, or standard therapy considered unsuitable or intolerable to the participant
Other cancer therapies are allowed, including investigational drugs, if any treatment-related toxicities (excluding alopecia) have resolved to grade = 1 or to laboratory values as defined by the protocol
Measurable disease at baseline as assessed by the Investigator per RECIST v1.1 or RANO criteria (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 if asymptomatic 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 and prior to the first dose of study drug
Women of childbearing potential must agree to remain abstinent or use contraceptive methods as defined by the protocol and refrain from donating eggs during the treatment period 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 the protocol and refrain from donating sperm during the treatment period and for at least 90 days after the last dose of alectinib
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of alectinib
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 CNS tumors are allowed
Malabsorption syndrome or any other condition that would interfere with enteral absorption
Incomplete recovery from any surgery prior to treatment
Any other malignancies within 5 years prior to enrollment, except for those described in the protocol
Any serious medical condition or abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study
History of hypersensitivity to any of the ingredients in the alectinib drug formulation
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