CompletedNCT01613768Updated Sep 28, 2018Results posted

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

A Phase 2 interventional study of eribulin mesylate in Recurrent Salivary Gland Cancer, Stage IVA Salivary Gland Cancer and Stage IVB Salivary Gland Cancer, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-28.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 29
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

Researchers are doing a research study to examine the use of eribulin (eribulin mesylate) in patients with salivary gland cancer. Researchers want to know if eribulin is safe and effective in treating salivary gland cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. Evaluate the response rate of eribulin per Response Evaluation Criteria In Solid Tumors (RECIST) in patients with locally advanced refractory or metastatic salivary gland cancer (SGC).

SECONDARY OBJECTIVES:

I. Determine the safety and toxicity of eribulin in patients with locally advanced refractory or metastatic SGC.

II. Evaluate the duration of response and time-to-progression.

OUTLINE:

Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days.

Conditions studied

Recurrent Salivary Gland Cancer
Stage IVA Salivary Gland Cancer
Stage IVB Salivary Gland Cancer
Stage IVC Salivary Gland Cancer

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Salivary Gland Neoplasms 156

In context

Salivary Gland Neoplasms

156 studies on the registry are indexed under Salivary Gland Neoplasms; 29 are open to participants now.

This study's enrollment of 29 is below the median of 36 across 133 interventional studies indexed under Salivary Gland Neoplasms.

Browse Salivary Gland Neoplasms studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients must have histologically or cytologically documented salivary gland cancers; patients that do not have a salivary gland primary must have one of the following histologies - adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma
Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy occurring within 6 months of study entry, as evidenced by: at least a 20% increase in radiographically or clinically measurable disease, appearance of any new lesions, or deterioration in clinical status
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Patients with measurable disease per RECIST 1.1 criteria
- At least one lesion of >= 1.5 cm in long-axis diameter for non lymph nodes or >= 1.5 cm in short-axis diameter for lymph nodes which is serially measurable according to RECIST 1.1 using either computerized tomography (CT) or magnetic resonance imaging (MRI)
- Lesions that have had radiotherapy must show evidence of progressive disease (PD) based on RECIST 1.1 to be deemed a target lesion
Absolute neutrophil count >= 1,500/μL
Platelets >= 100,000/μL
Creatinine clearance >= 40 mL/min
Bilirubin =\< 1.5 upper limit of normal (ULN)
Alkaline phosphatase =\< 3 ULN; if total ALP is > 3 x ULN (in the absence of liver metastasis) or > 5 x ULN in subjects with liver metastasis AND the subject is known to have bone metastases, then liver ALP iso-enzyme should be used to assess liver function rather than total ALP
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 X ULN
Women of child-bearing potential (WOCP) and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation
Life expectancy of > 12 weeks
Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment

Exclusion criteria

Exclusion Criteria:

Patients with symptomatic central nervous system (CNS) metastases must have stable disease after treatment with surgery or radiation therapy
Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
Radiotherapy within 14 days of study treatment
Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
Treatment with any chemotherapy or investigational agents within 4 weeks of the start of study treatment; subjects must have recovered from toxicities of prior therapy
Patients with peripheral neuropathy >= grade 2
Significant cardiovascular impairment: congestive heart failure > class II according to the New York Heart Association (NYHA), unstable angina or myocardial infarction within 6 months of enrollment, or serious cardiac arrhythmia (> grade 2)
Concomitant severe or uncontrolled medical disease
Significant psychiatric or neurologic disorder which would compromise participation in the study
Pregnant or breast-feeding females

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 29 participants (actual)

Study arms

Experimental
Treatment (eribulin mesylate)
Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: eribulin mesylate

Interventions

Drugeribulin mesylate
Given IV
Also known as: B1939, E7389, ER-086526, halichrondrin B analog

What researchers measure

Primary outcomes

Response Rate
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 frame: 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.

Secondary outcomes

Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only)
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 frame: 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.
Time to Progression
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 frame: 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.
Disease Control Rate (DCR)
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 frame: 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.
Toxicity Rates
Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0
Time frame: 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.

Results

Posted Aug 10, 2018

Participant flow

Seattle Cancer Care Alliance/University of Washington Phase II open label study enrolled patients at a single site between May 2012 and August 2015.

Participant flow — Overall Study
Milestone	Treatment (Eribulin Mesylate)
Started	29
Completed	29
Not completed	0

Outcome measures

PrimaryResponse Rate

Time frame:: 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.
Reported as:: Count of participants · Participants

Response Rate
Participants	Treatment (Eribulin Mesylate)
Complete Response (CR)	1
Partial Response (PR)	2
Stable Disease (SD)	23
Progressive Disease (PD)	3

SecondaryDuration of Tumor Response (Complete (CR) and Partial (PR) Response Only)

Time frame:: 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.
Reported as:: Median · weeks

Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only)
weeks	Treatment (Eribulin Mesylate)
Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only)	33.7 (24.0 to 77.9)

SecondaryTime to Progression

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 frame:: 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.
Reported as:: Median · Weeks

Time to Progression
Weeks	Treatment (Eribulin Mesylate)
Time to Progression	18.0 (5.7 to 110.9)

SecondaryDisease Control Rate (DCR)

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 frame:: 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.
Reported as:: Count of participants · Participants

Disease Control Rate (DCR)
Participants	Treatment (Eribulin Mesylate)
Disease Control Rate (DCR)	26

SecondaryToxicity Rates

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

Time frame:: 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.
Reported as:: Count of participants · Participants

Toxicity Rates
Participants	Treatment (Eribulin Mesylate)
Toxicity Rates	14

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment (Eribulin Mesylate)	0/29 (0%)	3/29 (10.3%)	16/29 (55.2%)

Most frequent serious events

Most frequent serious events
Event	Treatment (Eribulin Mesylate)
Febrile neutropeniaBlood and lymphatic system disorders	1/29
Pathological spinal fractureMusculoskeletal and connective tissue disorders	1/29
EpistaxisRespiratory, thoracic and mediastinal disorders	1/29

Most frequent other events

Most frequent other events
Event	Treatment (Eribulin Mesylate)
Neutrophil count decreasedInvestigations	8/29
Peripheral sensory neuropathyNervous system disorders	7/29
FatigueGeneral disorders	4/29
MalaiseGeneral disorders	2/29
Creatinine increasedInvestigations	2/29

Baseline characteristics

Baseline participant measures are based on total eligible, consented and treated patients.

Age, Categorical
Age, Categorical(Participants)	Treatment (Eribulin Mesylate)
<=18 years	0
Between 18 and 65 years	15
>=65 years	14

Age, Continuous
Age, Continuous(years)	Treatment (Eribulin Mesylate)
Median	63 (23 to 79)

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment (Eribulin Mesylate)
Female	9
Male	20

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Treatment (Eribulin Mesylate)
Hispanic or Latino	0
Not Hispanic or Latino	28
Unknown or Not Reported	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Treatment (Eribulin Mesylate)
American Indian or Alaska Native	0
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	0
White	26
More than one race	0
Unknown or Not Reported	1

Region of Enrollment
Region of Enrollment(Participants)	Treatment (Eribulin Mesylate)
United States	29

Study locations

1 site

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington 98109, United States

References and documents

Study documents

Protocol and statistical analysis plan · Feb 14, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01613768
Lead sponsor: University of Washington
Collaborators: National Cancer Institute (NCI)
Responsible party: Renato Martins (Principal Investigator, University of Washington) — Principal investigator
First posted: Jun 7, 2012
Start date: May 8, 2012
Primary completion: Aug 23, 2017
Completion: Aug 23, 2017
Results posted: Aug 10, 2018
Last update: Sep 28, 2018

Study contacts

Renato Martins, MD, MPH

principal investigator · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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