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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Open-Label, Single Arm Decentralized Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors

Conditions
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Neoplasms, Colorectal Neoplasms, Melanoma, Pancreatic Neoplasms, Sarcoma, Ovarian Neoplasms, Brain Neoplasms, Thyroid Neoplasms, Neuroendocrine Tumors, Cholangiocarcinoma, Salivary Gland Neoplasms, Head and Neck Neoplasms, Thyroid Cancer, Papillary, Lymphoma, Large-Cell, Anaplastic, Neoplasms by Site, Respiratory Tract Neoplasms, Thoracic Neoplasms, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Central Nervous System

Intervention / Treatment
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* Drug: Alectinib


Participation Criteria
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Eligibility Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALK-positive Solid Tumors<br>Participants with locally advanced or metastatic ALK-positive tumors will receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason. | Drug: Alectinib<br>* Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.<br>* Other names: Alecensa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) |  | Approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1 |  | 0 days | 
| Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1 |  | From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years) | 
| Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1 |  | From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years) | 
| Central Nervous System (CNS) ORR by BICR Per RECIST v1.1 |  | Baseline up to 5 years | 
| CNS DOR by BICR Per RECIST v1.1 |  | From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years) | 
| Overall Survival (OS) |  | From the first dose of study drug to death from any cause (up to 5 years) | 
| Percentage of Participants With Adverse Events (AEs) |  | Approximately 1 year | 
| Percentage of Participants With Serious Adverse Events (SAEs) |  | Approximately 1 year | 
| Plasma Concentration of Alectinib |  | Baseline up to 5 years | 
| ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria |  | Up to 5 years | 
| DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria |  | From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years) | 
| PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria |  | From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years) | 
| OS in Participants With Primary CNS Tumors |  | From the first dose of study drug to death from any cause (up to 5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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agnostic, ALK+, Alk-positive, ALK positive, ALK mutation, GI, breast, sarcoma, neuroendocrine, female reproductive, ALK, ALK fusions, ALK gene rearrangements, colorectal cancer, entrectinib, basket study, salivary gland cancers, primary brain tumors, melanoma, sarcomas, papillary thyroid cancer, renal cell cancer, pancreatic cancer, breast cancer, cholangiocarcinoma, head & neck cancers, ovarian cancer, anaplastic lymphoma kinase positive, solid tumors, ALK+ solid tumors