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← AVGEMSI: metastatic Pancreatic cancer (first-line)

NCT04644315 · STUDY IN CONTEXT

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

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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

Confirmed ORR was defined as the proportion of participants with a complete or partial response (CR or PR) confirmed at least 28 days after initial response.

→

secondary · POSTED

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

BICR was not performed.

→

secondary · POSTED

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

DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

→

secondary · POSTED

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

PFS was defined as the time from the first dose of alectinib to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

→

secondary · POSTED

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

CNS ORR was defined as the objective tumor response rate (CR or PR) of CNS lesions and could not be calculated due to an insufficient number of participants with the event.

→

secondary · POSTED

CNS DOR by BICR Per RECIST v1.1

CNS DOR was defined as the time from the first observation of CNS response until the first observation of CNS progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer-avgemsi-9fcc56af
nct id
NCT04644315
trial label
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0000
    source section id
    NCT04644315-om-0000
    source outcome index
    0
    endpoint
    Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
    endpoint definition
    Confirmed Objective Response Rate (ORR) as Determined by the Investigator Per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
    time origin
    Approximately 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Confirmed ORR was defined as the proportion of participants with a complete or partial response (CR or PR) confirmed at least 28 days after initial response.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0001
    source section id
    NCT04644315-om-0001
    source outcome index
    1
    endpoint
    Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
    endpoint definition
    Confirmed ORR as Determined by Blinded Independent Center Review (BICR) Per RECIST v1.1
    time origin
    0 days
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    BICR was not performed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0002
    source section id
    NCT04644315-om-0002
    source outcome index
    2
    endpoint
    Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1
    endpoint definition
    Duration of Response (DOR) as Determined by Both the Investigator and by BICR Per RECIST v1.1
    time origin
    From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0003
    source section id
    NCT04644315-om-0003
    source outcome index
    3
    endpoint
    Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1
    endpoint definition
    Progression-Free Survival (PFS) as Determined by Both the Investigator and by BICR Per RECIST v1.1
    time origin
    From first dose of alectinib to disease progression or death from any cause, whichever occurs first (up to 5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PFS was defined as the time from the first dose of alectinib to disease progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0004
    source section id
    NCT04644315-om-0004
    source outcome index
    4
    endpoint
    Central Nervous System (CNS) ORR by BICR Per RECIST v1.1
    endpoint definition
    Central Nervous System (CNS) ORR by BICR Per RECIST v1.1
    time origin
    Baseline up to 5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    CNS ORR was defined as the objective tumor response rate (CR or PR) of CNS lesions and could not be calculated due to an insufficient number of participants with the event.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0005
    source section id
    NCT04644315-om-0005
    source outcome index
    5
    endpoint
    CNS DOR by BICR Per RECIST v1.1
    endpoint definition
    CNS DOR by BICR Per RECIST v1.1
    time origin
    From the first observation of CNS response to the first observation of CNS progression or death from any cause (up to 5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    CNS DOR was defined as the time from the first observation of CNS response until the first observation of CNS progression or death from any cause and could not be calculated due to an insufficient number of participants with the event.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0000
    arm key
    OG000
    arm label
    ALK-positive Solid Tumors
    regimen
    Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644315-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0001
    arm key
    OG000
    arm label
    ALK-positive Solid Tumors
    regimen
    Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644315-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0002
    arm key
    OG000
    arm label
    ALK-positive Solid Tumors
    regimen
    Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644315-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0003
    arm key
    OG000
    arm label
    ALK-positive Solid Tumors
    regimen
    Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644315-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0004
    arm key
    OG000
    arm label
    ALK-positive Solid Tumors
    regimen
    Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644315-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    outcome key
    om-0005
    arm key
    OG000
    arm label
    ALK-positive Solid Tumors
    regimen
    Participants with locally advanced or metastatic ALK-positive tumors were to receive alectinib twice daily (BID) until disease progression, unacceptable toxicity, death, or withdrawal from the study for any reason.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04644315-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-pancreatic-cancer-avgemsi-9fcc56af
    nct id
    NCT04644315
    harm key
    EG000
    source section id
    NCT04644315-ae
    event group key
    EG000
    event group label
    ALK-positive Solid Tumors
    serious affected
    1
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    0
    collection period
    Approximately 1 year
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice