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: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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.

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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-intestinal-neoplasm
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: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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

release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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

release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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
release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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

release id
clinical-indications-draft-1
disease state id
ds-intestinal-neoplasm
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