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NeoplasmsPhase 2ALpha-TNCT04644315

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

A Phase 2 study testing Alectinib in people with Neoplasms and Colorectal Neoplasms, run by Hoffmann-La Roche at 29 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Colorectal Neoplasms, Melanoma
What is being tested?
Alectinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
29 sitesUnited States
Study dates
24 May 2021to 16 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Homebased Telemedicine

    Austin, Texas, 78701

  • Homebased Telemedicine

    Buffalo, New York, 14202

  • Science 37, Inc

    Culver City, California, 90230

  • Science 37-Basem; Dept 004- Basem

    Culver City, California, 90230

  • Science 37-Beg; Dept 001 Dr. M. Beg

    Culver City, California, 90230

  • Science 37-Cannon; Dept 002-Cannon

    Culver City, California, 90230

  • Science 37-Kurzrock; Dept 005-Kurzrock

    Culver City, California, 90230

  • Science 37-Thomas; Dept 006-Thomas

    Culver City, California, 90230

  • Homebased Telemedicine

    Dallas, Texas, 75202

  • Homebased Telemedicine

    Fort Wayne, Indiana, 46802

  • Homebased Telemedicine

    Houston, Texas, 77002

  • Homebased Telemedicine

    Indianapolis, Indiana, 46202

  • Homebased Telemedicine

    Jacksonville, Florida, 32202

  • Homebased Telemedicine

    Los Angeles, California, 90013

  • Homebased Telemedicine

    Miami, Florida, 33132

  • Homebased Telemedicine

    Minneapolis, Minnesota, 55401

  • Homebased Telemedicine

    New York, New York, 10038

  • Homebased Telemedicine

    Orlando, Florida, 32801

  • Homebased Telemedicine

    Philadelphia, Pennsylvania, 19103

  • Homebased Telemedicine

    Pittsburgh, Pennsylvania, 15282

  • Homebased Telemedicine

    Richmond, Virginia, 23220

  • Homebased Telemedicine

    Sacramento, California, 95814

  • Homebased Telemedicine

    Saint Paul, Minnesota, 55155

  • Homebased Telemedicine

    San Diego, California, 92101

  • Homebased Telemedicine

    San Francisco, California, 94104

  • Homebased Telemedicine

    San Jose, California, 95110

  • Homebased Telemedicine

    St Louis, Missouri, 63103

  • Homebased Telemedicine

    Tampa, Florida, 33601

  • Homebased Telemedicine

    Virginia Beach, Virginia, 23451

Other trials in United States

About this study

Official title: 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.

Being tested
Alectinib
Keywords
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
Medical subject headings
Neoplasms, Colorectal Neoplasms, Melanoma, Pancreatic Neoplasms, Sarcoma, Ovarian Neoplasms, Brain Neoplasms, Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlectinibDrug

    Also called Alecensa

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

Study groups in NCT04644315
Study groupRoleWhat they receive
ALK-positive Solid TumorsExperimentalParticipants 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.
Receives: Drug: Alectinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

    Measured: Approximately 1 year

Secondary outcomes (13)

  1. Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1

    Measured: 0 days

  2. Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1

    Measured: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)

  3. Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1

    Measured: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)

  4. Central Nervous System (CNS) ORR by BICR Per RECIST v1.1

    Measured: Baseline up to 5 years

  5. CNS DOR by BICR Per RECIST v1.1

    Measured: From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)

  6. Overall Survival (OS)

    Measured: From the first dose of study drug to death from any cause (up to 5 years)

  7. Percentage of Participants With Adverse Events (AEs)

    Measured: Approximately 1 year

  8. Percentage of Participants With Serious Adverse Events (SAEs)

    Measured: Approximately 1 year

  9. Plasma Concentration of Alectinib

    Measured: Baseline up to 5 years

  10. ORR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per Response Assessment in Neuro-Oncology (RANO) Criteria

    Measured: Up to 5 years

  11. DOR in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria

    Measured: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)

  12. PFS in Participants With Primary CNS Tumors as Determined by Both BICR and the Investigator Per RANO Criteria

    Measured: From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)

  13. OS in Participants With Primary CNS Tumors

    Measured: From the first dose of study drug to death from any cause (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2020
  2. Study start24 May 2021
  3. Primary completion16 May 2022
  4. Study completion16 May 2022

Why it stopped: The data from this study is no longer needed.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04644315
Sponsor's protocol ID
BO41929
Acronym
ALpha-T
Status last verified
Jul 2023
First submitted
20 Nov 2020
Last updated
7 Aug 2023
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alectinib in people with Neoplasms and Colorectal Neoplasms, run by Hoffmann-La Roche at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04644315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.

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