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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Terminated
CT.gov ID
NCT04644315
Collaborator
(none)
1
29
1
11.7
0
0

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 24, 2021
Actual Primary Completion Date :
May 16, 2022
Actual Study Completion Date :
May 16, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) [From 28 days after initial response up to 5 years]

    Secondary Outcome Measures

    1. Confirmed ORR as Determined by Blinded Independent Center Review (BICR) per RECIST v1.1 [From 28 days after initial response up to 5 years]

    2. 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)]

    3. 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)]

    4. Central Nervous System (CNS) ORR by BICR per RECIST v1.1 [Baseline up to 5 years]

    5. 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)]

    6. Overall Survival (OS) [From the first dose of study drug to death from any cause (up to 5 years)]

    7. Percentage of Participants with Adverse Events (AEs) [Up to 5 years]

    8. Percentage of Participants with Serious Adverse Events (SAEs) [Up to 5 years]

    9. Plasma Concentration of Alectinib [At pre-defined intervals from 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 [Up to 5 years]

    11. 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)]

    12. 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)]

    13. OS in Participants with Primary CNS Tumors [From the first dose of study drug to death from any cause (up to 5 years)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Science 37, Inc Culver City California United States 90230
    2 Science 37-Basem; Dept 004- Basem Culver City California United States 90230
    3 Science 37-Beg; Dept 001 Dr. M. Beg Culver City California United States 90230
    4 Science 37-Cannon; Dept 002-Cannon Culver City California United States 90230
    5 Science 37-Kurzrock; Dept 005-Kurzrock Culver City California United States 90230
    6 Science 37-Thomas; Dept 006-Thomas Culver City California United States 90230
    7 Homebased Telemedicine Los Angeles California United States 90013
    8 Homebased Telemedicine Sacramento California United States 95814
    9 Homebased Telemedicine San Diego California United States 92101
    10 Homebased Telemedicine San Francisco California United States 94104
    11 Homebased Telemedicine San Jose California United States 95110
    12 Homebased Telemedicine Jacksonville Florida United States 32202
    13 Homebased Telemedicine Miami Florida United States 33132
    14 Homebased Telemedicine Orlando Florida United States 32801
    15 Homebased Telemedicine Tampa Florida United States 33601
    16 Homebased Telemedicine Fort Wayne Indiana United States 46802
    17 Homebased Telemedicine Indianapolis Indiana United States 46202
    18 Homebased Telemedicine Minneapolis Minnesota United States 55401
    19 Homebased Telemedicine Saint Paul Minnesota United States 55155
    20 Homebased Telemedicine Saint Louis Missouri United States 63103
    21 Homebased Telemedicine Buffalo New York United States 14202
    22 Homebased Telemedicine New York New York United States 10038
    23 Homebased Telemedicine Philadelphia Pennsylvania United States 19103
    24 Homebased Telemedicine Pittsburgh Pennsylvania United States 15282
    25 Homebased Telemedicine Austin Texas United States 78701
    26 Homebased Telemedicine Dallas Texas United States 75202
    27 Homebased Telemedicine Houston Texas United States 77002
    28 Homebased Telemedicine Richmond Virginia United States 23220
    29 Homebased Telemedicine Virginia Beach Virginia United States 23451

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04644315
    Other Study ID Numbers:
    • BO41929
    First Posted:
    Nov 25, 2020
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022

    Study Results

    No Results Posted as of Jul 26, 2022