Trial · NCT01613768
Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
NCT01613768, Phase 2, Completed, University of Washington; results first posted 2018-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer. Trials, record NCT01613768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01613768
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer
- NCT number
- NCT01613768
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Recurrent Salivary Gland Cancer, Stage IVA Salivary Gland Cancer, Stage IVB Salivary Gland Cancer, Stage IVC Salivary Gland Cancer
- Interventions
- eribulin mesylate
- First posted
- 2012-06-07
- Last updated
- 2018-09-28
- Results first posted
- 2018-08-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | 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. | 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. |
| Secondary | Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only) | 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. | 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. |
| Secondary | Time to Progression | 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. | 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. |
| Secondary | Disease Control Rate (DCR) | 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. | 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. |
| Secondary | Toxicity Rates | 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. | Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | 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. | All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only) | 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. | 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. | weeks | MEDIAN |
| SECONDARY | Time to Progression | 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. | 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. | Weeks | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | 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. | All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Toxicity Rates | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Treatment (Eribulin Mesylate) | Complete Response (CR) | 1 | Participants | |
| Response Rate | Treatment (Eribulin Mesylate) | Partial Response (PR) | 2 | Participants | |
| Response Rate | Treatment (Eribulin Mesylate) | Stable Disease (SD) | 23 | Participants | |
| Response Rate | Treatment (Eribulin Mesylate) | Progressive Disease (PD) | 3 | Participants | |
| Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only) | Treatment (Eribulin Mesylate) | 33.7 | Full Range 24.0 to 77.9 | weeks | |
| Time to Progression | Treatment (Eribulin Mesylate) | 18.0 | Full Range 5.7 to 110.9 | Weeks | |
| Disease Control Rate (DCR) | Treatment (Eribulin Mesylate) | 26 | Participants | ||
| Toxicity Rates | Treatment (Eribulin Mesylate) | 14 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Eribulin Mesylate) | 29 | |
| Overall Study | COMPLETED | Treatment (Eribulin Mesylate) | 29 | |
| Overall Study | NOT COMPLETED | Treatment (Eribulin Mesylate) | 0 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Treatment (Eribulin Mesylate) | 4 | 29 | 4 |
| other | Malaise | General disorders | Treatment (Eribulin Mesylate) | 2 | 29 | 2 |
| other | Creatinine increased | Investigations | Treatment (Eribulin Mesylate) | 2 | 29 | 2 |
| other | Neutrophil count decreased | Investigations | Treatment (Eribulin Mesylate) | 8 | 29 | 14 |
| other | Peripheral sensory neuropathy | Nervous system disorders | Treatment (Eribulin Mesylate) | 7 | 29 | 10 |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Eribulin Mesylate) | 1 | 29 | 1 |
| serious | Pathological spinal fracture | Musculoskeletal and connective tissue disorders | Treatment (Eribulin Mesylate) | 1 | 29 | 1 |
| serious | Epistaxis | Respiratory, thoracic and mediastinal disorders | Treatment (Eribulin Mesylate) | 1 | 29 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Eribulin Mesylate) | 0 | 29 |
| Total, other adverse events | Treatment (Eribulin Mesylate) | 16 | 29 |
| Total, serious adverse events | Treatment (Eribulin Mesylate) | 3 | 29 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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