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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00892 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (eribulin mesylate) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eribulin mesylate | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Renato Martins, MD, MPH | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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Twenty-nine patients were consented and treated.
Seattle Cancer Care Alliance/University of Washington Phase II open label study enrolled patients at a single site between May 2012 and August 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Eribulin Mesylate) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2018 |
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| 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. | 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. | 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 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline participant measures are based on total eligible, consented and treated patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Eribulin Mesylate) | Patients receive 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. | Posted | Count of Participants | Participants | 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. |
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| Secondary | 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. | 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. | Posted | Median | Full Range | weeks | 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. |
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| Secondary | 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. | 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. | Posted | Median | Full Range | Weeks | 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. |
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| Secondary | 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. | All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. | Posted | Count of Participants | Participants | 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. |
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| Secondary | Toxicity Rates | Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0 | Posted | Count of Participants | Participants | 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. |
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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.
Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Eribulin Mesylate) | 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. | 0 | 29 | 3 | 29 | 16 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pathological spinal fracture | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Malaise | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Manager | University of Washington | 206-606-7445 | smasters@seattlecca.org |
| May 14, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D012466 | Salivary Gland Diseases |
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| ID | Term |
|---|---|
| C490954 | eribulin |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Progressive Disease (PD) |
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