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

July 17, 2023 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Culver City, California, United States, 90230
        • Science 37, Inc
      • Culver City, California, United States, 90230
        • Science 37-Basem; Dept 004- Basem
      • Culver City, California, United States, 90230
        • Science 37-Beg; Dept 001 Dr. M. Beg
      • Culver City, California, United States, 90230
        • Science 37-Cannon; Dept 002-Cannon
      • Culver City, California, United States, 90230
        • Science 37-Kurzrock; Dept 005-Kurzrock
      • Culver City, California, United States, 90230
        • Science 37-Thomas; Dept 006-Thomas
      • Los Angeles, California, United States, 90013
        • Homebased Telemedicine
      • Sacramento, California, United States, 95814
        • Homebased Telemedicine
      • San Diego, California, United States, 92101
        • Homebased Telemedicine
      • San Francisco, California, United States, 94104
        • Homebased Telemedicine
      • San Jose, California, United States, 95110
        • Homebased Telemedicine
    • Florida
      • Jacksonville, Florida, United States, 32202
        • Homebased Telemedicine
      • Miami, Florida, United States, 33132
        • Homebased Telemedicine
      • Orlando, Florida, United States, 32801
        • Homebased Telemedicine
      • Tampa, Florida, United States, 33601
        • Homebased Telemedicine
    • Indiana
      • Fort Wayne, Indiana, United States, 46802
        • Homebased Telemedicine
      • Indianapolis, Indiana, United States, 46202
        • Homebased Telemedicine
    • Minnesota
      • Minneapolis, Minnesota, United States, 55401
        • Homebased Telemedicine
      • Saint Paul, Minnesota, United States, 55155
        • Homebased Telemedicine
    • Missouri
      • Saint Louis, Missouri, United States, 63103
        • Homebased Telemedicine
    • New York
      • Buffalo, New York, United States, 14202
        • Homebased Telemedicine
      • New York, New York, United States, 10038
        • Homebased Telemedicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Homebased Telemedicine
      • Pittsburgh, Pennsylvania, United States, 15282
        • Homebased Telemedicine
    • Texas
      • Austin, Texas, United States, 78701
        • Homebased Telemedicine
      • Dallas, Texas, United States, 75202
        • Homebased Telemedicine
      • Houston, Texas, United States, 77002
        • Homebased Telemedicine
    • Virginia
      • Richmond, Virginia, United States, 23220
        • Homebased Telemedicine
      • Virginia Beach, Virginia, United States, 23451
        • Homebased Telemedicine

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other Names:
  • Alecensa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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)
Time Frame: Approximately 1 year
Approximately 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: From the first dose of study drug to death from any cause (up to 5 years)
From the first dose of study drug to death from any cause (up to 5 years)
Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
Time Frame: 0 days
0 days
Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1
Time Frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
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
Time Frame: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
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
Time Frame: Baseline up to 5 years
Baseline up to 5 years
CNS DOR by BICR Per RECIST v1.1
Time Frame: From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)
From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)
Percentage of Participants With Adverse Events (AEs)
Time Frame: Approximately 1 year
Approximately 1 year
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Approximately 1 year
Approximately 1 year
Plasma Concentration of Alectinib
Time Frame: Baseline up to 5 years
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
Time Frame: Up to 5 years
Up to 5 years
DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria
Time Frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
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
Time Frame: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
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
Time Frame: From the first dose of study drug to death from any cause (up to 5 years)
From the first dose of study drug to death from any cause (up to 5 years)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BO41929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings