Trial Outcomes & Findings for Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma (NCT NCT02097238)

NCT ID: NCT02097238

Last Updated: 2020-05-19

Results Overview

The number of patients who do not experience disease progression or death in the four months following enrollment on AOST1322.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

4 Months

Results posted on

2020-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	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. Eribulin Mesylate: Given IV Pharmacological Study: Correlative studies
Overall Study STARTED	19
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Eribulin Mesylate: Given IV Pharmacological Study: Correlative studies
Overall Study Death	1
Overall Study Physician Decision	1
Overall Study Progressive Disease	17

Baseline Characteristics

Eribulin Mesylate in Treating Patients With Recurrent or Refractory Osteosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Eribulin Mesylate) n=19 Participants 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.
Age, Continuous	17 Years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Canada	2 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Months

The number of patients who do not experience disease progression or death in the four months following enrollment on AOST1322.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=19 Participants 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.
Disease Control Success	0 participants

PRIMARY outcome

Timeframe: 4 months

The number of patients who experience a complete or partial response according to the RECIST criteria as defined in Eisenhauer et al. Eur J Cancer 45:228-47, 2009.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=19 Participants 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.
Response Evaluation Criteria in Solid Tumors (RECIST) Response	0 participants

SECONDARY outcome

Timeframe: 4 months

Population: 19 patients were treated on protocol therapy. Thirty-nine cycles were reported for the analysis of dose limiting toxicity.

Each cycle where the patient receives eribulin and does not receive non-protocol 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 non-hematological toxicity attributable to the investigational drug and does not resolve to meet eligibility or baseline criteria by day 11. Any \>= grade 3 non-hematological 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 alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/gamma-glutamyltransferase (GGT), that returns to grade =\< 1 or baseline prior to the time for the next treatment cycle.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=39 Cycles 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.
Number of Cycles Where a Dose Limiting Toxicity Was Identified	2 Cycles

SECONDARY outcome

Timeframe: Cycle 1 day 1 and cycle 2 day 1 at the end of infusion, 0.5-6 hours, and 24-120 hours post infusion; cycle 1 day 8 and cycle 2 day 8 prior to the dose of eribulin and at the end of infusion

Population: 5 patients contributed 9 cycles for the calculation of the sample mean and standard deviation of Area under the curve

Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the area under the curve will be reported The analytic unit 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.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=9 patient-cycles 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.
Area Under the Curve 0-infinity of Eribulin Mesylate in Ng-hr/ml	2475.293034 hour-nanograms/mL Standard Deviation 1746.75558

SECONDARY outcome

Population: 5 patients contributed 9 cycles for the calculation of the sample mean and standard deviation of clearance

Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the clearance will be reported. The analytic unit 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.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=9 patient-cycles 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.
Clearance of Eribulin Mesylate in L/hr	1.585078903 L/hour Standard Deviation 1.08079608

SECONDARY outcome

Timeframe: 1 day 1 and cycle 2 day 1 at the end of infusion, 0.5-6 hours, and 24-120 hours post infusion; cycle 1 day 8 and cycle 2 day 8 prior to the dose of eribulin and at the end of infusion

Population: 5 patients contributed 9 cycles for the calculation of the sample mean and standard deviation of half life

Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the half life will be reported. The analytic unit 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.

Outcome measures

Outcome measures
Measure	Treatment (Eribulin Mesylate) n=9 patient-cycles 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.
A Half Life of Eribulin Mesylate in hr	40.22202016 hours Standard Deviation 2475.293034

Adverse Events

Treatment (Eribulin Mesylate)

Serious events: 10 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Eribulin Mesylate) n=19 participants at risk 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.
Cardiac disorders Pericardial effusion	5.3% 1/19 • Number of events 1
Eye disorders Papilledema	5.3% 1/19 • Number of events 1
Injury, poisoning and procedural complications Fracture	5.3% 1/19 • Number of events 1
Metabolism and nutrition disorders Hyponatremia	5.3% 1/19 • Number of events 1
Musculoskeletal and connective tissue disorders Pain in extremity	10.5% 2/19 • Number of events 2
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	5.3% 1/19 • Number of events 1
Nervous system disorders Nervous system disorders - Other, specify	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders Atelectasis	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 1/19 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Eribulin Mesylate) n=19 participants at risk 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.
Investigations Neutrophil count decreased	21.1% 4/19 • Number of events 4
Investigations White blood cell decreased	5.3% 1/19 • Number of events 1
Respiratory, thoracic and mediastinal disorders Hypoxia	5.3% 1/19 • Number of events 1

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60