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
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Osteosarcoma||Drug: Eribulin Mesylate Other: Pharmacological Study||Phase 2|
I. To estimate the 4 month progression free survival rate and objective response rate in patients with recurrent osteosarcoma who are administered eribulin (eribulin mesylate) therapy on day 1 and day 8 of 21 day cycles.
I. To investigate the pharmacokinetics (PK) of eribulin in subjects with recurrent osteosarcoma.
II. To further describe the tolerability of single agent eribulin.
Patients receive eribulin mesylate intravenously (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.
After completion of study treatment, patients are followed up annually for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Eribulin (NSC# 707389) in Recurrent or Refractory Osteosarcoma|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Treatment (eribulin mesylate)
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.
Drug: Eribulin Mesylate
Other: Pharmacological Study
- Disease Control Success [ Time Frame: Four Months following enrollment on the study ]The number of patients who do not experience disease progression or death in the four months following enrollment on AOST1322.
- RECIST Response [ Time Frame: First 5 cycles of protocol therapy ]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.
- Number of Cycles Where a Dose Limiting Toxicity Was Identified [ Time Frame: 39 cycles were considered for this analysis ]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.
- PK Parameters of Eribulin Mesylate [ Time Frame: Per Cycle Incidence of dose limiting toxicity. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097238
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|Principal Investigator:||Michael Isakoff||Children's Oncology Group|