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NCT04644315 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2023-08-07

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

CNS DOR by BICR Per RECIST v1.1

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Percentage of Participants With Adverse Events (AEs)

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outcome · POSTED

Percentage of Participants With Serious Adverse Events (SAEs)

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outcome · POSTED

Plasma Concentration of Alectinib

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

OS in Participants With Primary CNS Tumors

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Alectinib
    label
    ALK-positive Solid Tumors
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. ALK-positive Solid Tumors
    description
    Participants will receive 600 mg oral alectinib BID until disease progression, unacceptable toxicity, withdrawal from treatment, or death.
    name
    Alectinib
    other Names
    1. Alecensa
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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
secondary Outcomes
  1. measure
    Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
    time Frame
    0 days
  2. measure
    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)
  3. measure
    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)
  4. measure
    Central Nervous System (CNS) ORR by BICR Per RECIST v1.1
    time Frame
    Baseline up to 5 years
  5. measure
    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)
  6. measure
    Overall Survival (OS)
    time Frame
    From the first dose of study drug to death from any cause (up to 5 years)
  7. measure
    Percentage of Participants With Adverse Events (AEs)
    time Frame
    Approximately 1 year
  8. measure
    Percentage of Participants With Serious Adverse Events (SAEs)
    time Frame
    Approximately 1 year
  9. measure
    Plasma Concentration of Alectinib
    time Frame
    Baseline up to 5 years
  10. measure
    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
  11. measure
    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)
  12. measure
    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)
Full 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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice