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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • 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

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
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.
Other Names:
  • Alecensa

What is the study measuring?

Primary Outcome Measures

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

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

Hoffmann-La Roche

Investigators

  • 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)

May 24, 2021

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

November 20, 2020

First Submitted That Met QC Criteria

November 20, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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