A Home-Based Approach Study To Evaluate The Efficacy And Safety Of Alectinib In Locally-Advanced Or Metastatic ALK-Positive Solid Tumors

Study Overview

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.

N/A

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

DRUG: Alectinib

BO41929

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-11-20	Results First Submitted 2023-04-21	Last Update Submitted that met QC Criteria 2023-07-17
First Submitted that Met QC Criteria 2020-11-20	Results First Submitted that Met QC Criteria 2023-07-17	Last Update Posted (ACTUAL) 2023-08-07
First Posted (ACTUAL) 2020-11-25	Results First Posted 2023-08-07	Last Verified 2023-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ALK-positive Solid Tumors 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 Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: ALK-positive Solid Tumors

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

Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.

Primary Outcome Measures	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	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)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Clinical Trials, Hoffmann-La Roche

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record