TriangleNCT03441360 · STUDY IN CONTEXT
Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sar
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Percentage of participants achieving a best objective response of partial response (PR) or complete response (CR) per RECIST 1.1, by up to 24 weeks after all participants have completed response assessment. Response assessment was determined by investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
PFS was defined as the time from the first dose date to the date of PD or date of death (whichever occurred first). PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). Data for this secondary endpoint was collected and analyzed up to the primary completion date (PCD). As there was no further data collected, therefore data is reported till PCD only.
An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline) or (1) reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
Laboratory results were graded using CTCAE Version 4.03. As per CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences. Data for this secondary endpoint was collected and analyzed up to the PCD. As there was no further data collected, therefore data is reported till PCD only.
Data for this secondary endpoint was collected and analyzed up to the PCD. As there was no further data collected, therefore data is reported till PCD only.
Data for this secondary endpoint was collected and analyzed up to the PCD. As there was no further data collected, therefore data is reported till PCD only.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- trial label
- Study to Assess Safety and Preliminary Activity of Eribulin Mesylate in Pediatric Participants With Relapsed/Refractory Rhabdomyosarcoma (RMS), Non-rhabdomyosarcoma Soft Tissue Sar
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0000
- source section id
- NCT03441360-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Objective Response
- endpoint definition
- Percentage of participants achieving a best objective response of partial response (PR) or complete response (CR) per RECIST 1.1, by up to 24 weeks after all participants have completed response assessment. Response assessment was determined by investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in the short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- time origin
- From date of randomization up to first documentation of disease progression (PD) or date of death, whichever occurred first (approximately 32 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The FAS included all participants who receive at least 1 dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0001
- source section id
- NCT03441360-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- PFS was defined as the time from the first dose date to the date of PD or date of death (whichever occurred first). PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions was also considered progression). Data for this secondary endpoint was collected and analyzed up to the primary completion date (PCD). As there was no further data collected, therefore data is reported till PCD only.
- time origin
- From the time from the first dose date to the date of disease progression (PD) or date of death, whichever occurred first (up to approximately 32 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The FAS included all participants who receive at least 1 dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0002
- source section id
- NCT03441360-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Any Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- endpoint definition
- An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline) or (1) reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.
- time origin
- From date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 45 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety analysis set included all participants who receive at least 1 dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0003
- source section id
- NCT03441360-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With a Shift From Baseline to Worst Post-Baseline Common Terminology Criteria for Adverse Events (CTCAE) Grade in Laboratory Value
- endpoint definition
- Laboratory results were graded using CTCAE Version 4.03. As per CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences. Data for this secondary endpoint was collected and analyzed up to the PCD. As there was no further data collected, therefore data is reported till PCD only.
- time origin
- From first dose of study drug up to approximately 32 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety analysis set included all participants who receive at least 1 dose of study drug. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given categories with non-missing data at both baseline and any post-baseline.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0004
- source section id
- NCT03441360-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values
- endpoint definition
- Data for this secondary endpoint was collected and analyzed up to the PCD. As there was no further data collected, therefore data is reported till PCD only.
- time origin
- From first dose of study drug up to approximately 32 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety analysis set included all participants who receive at least 1 dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0005
- source section id
- NCT03441360-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
- endpoint definition
- Data for this secondary endpoint was collected and analyzed up to the PCD. As there was no further data collected, therefore data is reported till PCD only.
- time origin
- From first dose of study drug up to approximately 32 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The safety analysis set included all participants who receive at least 1 dose of study drug.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Eribulin Mesylate 1.4 mg/m^2: RMS
- regimen
- Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Eribulin Mesylate 1.4 mg/m^2: NRSTS
- regimen
- Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Eribulin Mesylate 1.4 mg/m^2: EWS
- regimen
- Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Eribulin Mesylate 1.4 mg/m^2: RMS
- regimen
- Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Eribulin Mesylate 1.4 mg/m^2: NRSTS
- regimen
- Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Eribulin Mesylate 1.4 mg/m^2: EWS
- regimen
- Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Eribulin Mesylate 1.4 mg/m^2: RMS
- regimen
- Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Eribulin Mesylate 1.4 mg/m^2: NRSTS
- regimen
- Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Eribulin Mesylate 1.4 mg/m^2: EWS
- regimen
- Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Eribulin Mesylate 1.4 mg/m^2: RMS
- regimen
- Pediatric participants with RMS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Eribulin Mesylate 1.4 mg/m^2: NRSTS
- regimen
- Pediatric participants with non-rhabdomyosarcoma solid tumor sarcoma (NRSTS) received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Eribulin Mesylate 1.4 mg/m^2: EWS
- regimen
- Pediatric participants with EWS received eribulin mesylate as an IV infusion on Days 1 and 8 of each 21-day cycle at a dose of 1.4 mg/m\^2. Participants continued to receive study therapy until progression of disease, (per RECIST 1.1), exhibited no clinical benefit, intolerable toxicity, withdrawal of consent or termination of the study program, whichever occurred first.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03441360-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- harm key
- EG000
- source section id
- NCT03441360-ae
- event group key
- EG000
- event group label
- Eribulin Mesylate 1.4 mg/m^2: RMS
- serious affected
- 6
- serious at risk
- 8
- other affected
- 8
- other at risk
- 8
- frequency threshold
- 5
- collection period
- From date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 45 months)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- harm key
- EG001
- source section id
- NCT03441360-ae
- event group key
- EG001
- event group label
- Eribulin Mesylate 1.4 mg/m^2: NRSTS
- serious affected
- 2
- serious at risk
- 8
- other affected
- 8
- other at risk
- 8
- frequency threshold
- 5
- collection period
- From date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 45 months)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03441360
- harm key
- EG002
- source section id
- NCT03441360-ae
- event group key
- EG002
- event group label
- Eribulin Mesylate 1.4 mg/m^2: EWS
- serious affected
- 3
- serious at risk
- 5
- other affected
- 5
- other at risk
- 5
- frequency threshold
- 5
- collection period
- From date of administration of first dose up to 28 days after the last dose, or until resolution, whichever came first (up to approximately 45 months)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice