Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer

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

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, summarized using frequencies and percentages.

All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.

→

secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, reported as median values.

Participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline who achieved a CR or PR per RECIST 1.1.

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secondary · POSTED

Either 1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Progressive Disease (PD), \> 20% increase in the sum of the longest diameter (SLD) target lesions taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir; or 2. Radiographic progression per treating physician CT or MRI scan review.

All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. Does not include 7 patients taken off study before radiological progression: Toxicity = 3, Clinical PD = 4.

→

secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage (compared to baseline) to qualify for partial or complete response (CR or PR) nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD); Disease Control Rate (DCR) = CR + PR +SD.

All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.

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secondary · POSTED

Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0

Source null

→

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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id: NCT01613768
trial label: Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
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: 5
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0000
source section id
NCT01613768-om-0000
source outcome index
0
endpoint
Response Rate
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, summarized using frequencies and percentages.
time origin
From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0001
source section id
NCT01613768-om-0001
source outcome index
1
endpoint
Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only)
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, reported as median values.
time origin
From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline who achieved a CR or PR per RECIST 1.1.
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0002
source section id
NCT01613768-om-0002
source outcome index
2
endpoint
Time to Progression
endpoint definition
Either 1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Progressive Disease (PD), \> 20% increase in the sum of the longest diameter (SLD) target lesions taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir; or 2. Radiographic progression per treating physician CT or MRI scan review.
time origin
From date of first study therapy until date of first documented disease progression or date of death from any cause, whichever occurred first, assessed up to 36 days post last dose of study therapy.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. Does not include 7 patients taken off study before radiological progression: Toxicity = 3, Clinical PD = 4.
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0003
source section id
NCT01613768-om-0003
source outcome index
3
endpoint
Disease Control Rate (DCR)
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage (compared to baseline) to qualify for partial or complete response (CR or PR) nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD); Disease Control Rate (DCR) = CR + PR +SD.
time origin
From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0004
source section id
NCT01613768-om-0004
source outcome index
4
endpoint
Toxicity Rates
endpoint definition
Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0
time origin
Adverse events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy.
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0000
arm key
OG000
arm label
Treatment (Eribulin Mesylate)
regimen
Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01613768-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0001
arm key
OG000
arm label
Treatment (Eribulin Mesylate)
regimen
Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01613768-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0002
arm key
OG000
arm label
Treatment (Eribulin Mesylate)
regimen
Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
22
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01613768-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0003
arm key
OG000
arm label
Treatment (Eribulin Mesylate)
regimen
Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01613768-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
outcome key
om-0004
arm key
OG000
arm label
Treatment (Eribulin Mesylate)
regimen
Eribulin mesylate (1.4 mg/m2) administered intravenously (IV) over 2-5 minutes on days 1 and 8 of a 21 day cycle. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. eribulin mesylate: Given IV
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01613768-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
nct id
NCT01613768
harm key
EG000
source section id
NCT01613768-ae
event group key
EG000
event group label
Treatment (Eribulin Mesylate)
serious affected
3
serious at risk
29
other affected
16
other at risk
29
frequency threshold
5
collection period
Adverse events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy.
event definition
Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
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