TriangleNCT01613768 · STUDY IN CONTEXT
Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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
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.
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.
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.
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.
Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0
Reported safety
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-salivary-gland-cancer-recurrent-79ac7906
- nct id
- NCT01613768
- trial label
- Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent 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
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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-salivary-gland-cancer-recurrent-79ac7906
- 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