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Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma

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ClinicalTrials.gov Identifier: NCT02097238
Recruitment Status : Completed
First Posted : March 27, 2014
Results First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Osteosarcoma
Interventions Drug: Eribulin Mesylate
Other: Pharmacological Study
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description

Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Eribulin Mesylate: Given IV

Pharmacological Study: Correlative studies

Period Title: Overall Study
Started 19
Completed 0
Not Completed 19
Reason Not Completed
Death             1
Physician Decision             1
Progressive Disease             17
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
17
(12 to 25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
7
  36.8%
Male
12
  63.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Hispanic or Latino
3
  15.8%
Not Hispanic or Latino
16
  84.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
1
   5.3%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  15.8%
White
14
  73.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   5.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants
Canada 2
United States 17
1.Primary Outcome
Title Disease Control Success
Hide Description The number of patients who do not experience disease progression or death in the four months following enrollment on AOST1322.
Time Frame Four Months following enrollment on the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:
Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title RECIST Response
Hide Description The number of patients who experience a complete or partial response according the the RECIST criteria as defined in Eisenhauer et al. Eur J Cancer 45:228-47, 2009.
Time Frame First 5 cycles of protocol therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:
Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Number of Cycles Where a Dose Limiting Toxicity Was Identified
Hide Description Each cycle where the patient receives eribulin and does not receive nonprotocol anticancer therapy will be considered in the analysis. A dose limiting toxicity is defined to be: Day 8 eribulin dose is held due to Grade 3 or Grade 4 nonhematological toxicity attributable to the investigational drug and does not resolve to meet eligibility or baseline criteria by Day 11. Any ≥ Grade 3 nonhematological toxicity attributable to the investigational drug with the specific exclusion of: Grade 3 nausea and vomiting < 3 days duration Grade 3 liver enzyme elevation, including ALT/AST/GGT, that returns to Grade ≤ 1 or baseline prior to the time for the next treatment cycle.
Time Frame 39 cycles were considered for this analysis
Hide Outcome Measure Data
Hide Analysis Population Description
19 patients were treated on protocol therapy. Thirty-nine cycles were reported for the analysis of dose limiting toxicity.
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description:
Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 19
Overall Number of Units Analyzed
Type of Units Analyzed: Cycles
39
Measure Type: Number
Unit of Measure: Cycle
2
4.Secondary Outcome
Title PK Parameters of Eribulin Mesylate
Hide Description Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the area under the curve, clearance and half-life will be calculated. The analytic unit for monitoring for excessive toxicity will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.
Time Frame Per Cycle Incidence of dose limiting toxicity.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Eribulin Mesylate)
Hide Arm/Group Description Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Eribulin Mesylate)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Eribulin Mesylate)
Affected / at Risk (%) # Events
Total   10/19 (52.63%)    
Cardiac disorders   
Pericardial effusion  1/19 (5.26%)  1
Eye disorders   
Papilledema  1/19 (5.26%)  1
Injury, poisoning and procedural complications   
Fracture  1/19 (5.26%)  1
Metabolism and nutrition disorders   
Hyponatremia  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Pain in extremity  2/19 (10.53%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1/19 (5.26%)  1
Nervous system disorders   
Nervous system disorders - Other, specify  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1/19 (5.26%)  1
Dyspnea  1/19 (5.26%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Eribulin Mesylate)
Affected / at Risk (%) # Events
Total   6/19 (31.58%)    
Investigations   
Neutrophil count decreased  4/19 (21.05%)  4
White blood cell decreased  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1/19 (5.26%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-446-0064
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02097238     History of Changes
Other Study ID Numbers: NCI-2014-00621
NCI-2014-00621 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AOST1322
AOST1322 ( Other Identifier: Children's Oncology Group )
AOST1322 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: March 24, 2014
First Posted: March 27, 2014
Results First Submitted: November 29, 2016
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017