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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• 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 gradelaboratory 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

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 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