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Trial record 46 of 157 for:    eribulin

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

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ClinicalTrials.gov Identifier: NCT01613768
Recruitment Status : Completed
First Posted : June 7, 2012
Results First Posted : August 10, 2018
Last Update Posted : September 28, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Renato Martins, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Salivary Gland Cancer
Stage IVA Salivary Gland Cancer
Stage IVB Salivary Gland Cancer
Stage IVC Salivary Gland Cancer
Intervention Drug: eribulin mesylate
Enrollment 29
Recruitment Details Seattle Cancer Care Alliance/University of Washington Phase II open label study enrolled patients at a single site between May 2012 and August 2015.
Pre-assignment Details Twenty-nine patients were consented and treated.
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 29
Completed 29
Not Completed 0
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
Baseline participant measures are based on total eligible, consented and treated patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  51.7%
>=65 years
14
  48.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
63
(23 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
9
  31.0%
Male
20
  69.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
28
  96.6%
Unknown or Not Reported
1
   3.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   6.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
26
  89.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
 100.0%
1.Primary Outcome
Title Response Rate
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
1
   3.4%
Partial Response (PR)
2
   6.9%
Stable Disease (SD)
23
  79.3%
Progressive Disease (PD)
3
  10.3%
2.Secondary Outcome
Title Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only)
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: weeks
33.7
(24.0 to 77.9)
3.Secondary Outcome
Title Time to Progression
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 22
Median (Full Range)
Unit of Measure: Weeks
18.0
(5.7 to 110.9)
4.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
26
  89.7%
5.Secondary Outcome
Title Toxicity Rates
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
14
  48.3%
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.
Adverse Event Reporting Description Any adverse events leading to a treatment interruption or dose reduction along with all adverse events that are grade 3 and higher were recorded.
 
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description 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.
All-Cause Mortality
Treatment (Eribulin Mesylate)
Affected / at Risk (%)
Total   0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Eribulin Mesylate)
Affected / at Risk (%) # Events
Total   3/29 (10.34%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders   
Pathological spinal fracture * 1  1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  1/29 (3.45%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Eribulin Mesylate)
Affected / at Risk (%) # Events
Total   16/29 (55.17%)    
General disorders   
Fatigue * 1  4/29 (13.79%)  4
Malaise * 1  2/29 (6.90%)  2
Investigations   
Creatinine increased * 1  2/29 (6.90%)  2
Neutrophil count decreased * 1  8/29 (27.59%)  14
Nervous system disorders   
Peripheral sensory neuropathy * 1  7/29 (24.14%)  10
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Research Manager
Organization: University of Washington
Phone: 206-606-7445
Responsible Party: Renato Martins, University of Washington
ClinicalTrials.gov Identifier: NCT01613768     History of Changes
Other Study ID Numbers: 7674
NCI-2012-00892 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: June 5, 2012
First Posted: June 7, 2012
Results First Submitted: July 10, 2018
Results First Posted: August 10, 2018
Last Update Posted: September 28, 2018