TriangleNCT03245450 · STUDY IN CONTEXT
Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors
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
The RP2D was evaluated based on a review of the outcomes of safety (including dose limiting toxicities \[DLTs\]), tumor assessments, and pharmacokinetic (PK) in Phase 1 by investigators and the study team.
ORR was defined as the percentage of participants achieving best overall response (BOR) of confirmed partial response (PR) or complete response (CR) determined by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeter (mm). PR was at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters.
A TEAE was defined as an AE that emerged during treatment, having been absent at pretreatment, or reemerged during treatment, having been present at pre-treatment (baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
Phase 1, Cmax: Maximum Observed Plasma Concentration of Eribulin, Irinotecan and Its Active Metabolite SN-38
Phase 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Eribulin, Irinotecan and Its Active Metabolite SN-38
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
- NCT03245450
- trial label
- Study Evaluating the Safety and Efficacy of Eribulin Mesilate in Combination With Irinotecan Hydrochloride in Children With Refractory or Recurrent Solid Tumors
- 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
- 7
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0000
- source section id
- NCT03245450-om-0000
- source outcome index
- 0
- endpoint
- Phase 1: Recommended Phase 2 Dose (RP2D) of Eribulin Mesilate in Combination With Irinotecan Hydrochloride
- endpoint definition
- The RP2D was evaluated based on a review of the outcomes of safety (including dose limiting toxicities \[DLTs\]), tumor assessments, and pharmacokinetic (PK) in Phase 1 by investigators and the study team.
- time origin
- First dose of study drug up to Cycle 1 (Cycle length=21 days)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Dose Evaluable Set (DES) for Phase 1 included all the participants who completed Cycle 1 treatment and were evaluated for DLTs and those who discontinued treatment during Cycle 1 due to DLTs.
- 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
- NCT03245450
- outcome key
- om-0001
- source section id
- NCT03245450-om-0001
- source outcome index
- 1
- endpoint
- Phase 2: Objective Response Rate (ORR)
- endpoint definition
- ORR was defined as the percentage of participants achieving best overall response (BOR) of confirmed partial response (PR) or complete response (CR) determined by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeter (mm). PR was at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters.
- time origin
- From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or up to approximately 2 years 4 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Full analysis set included all participants who received at least 1 dose of either 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
- NCT03245450
- outcome key
- om-0002
- source section id
- NCT03245450-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- endpoint definition
- A TEAE was defined as an AE that emerged during treatment, having been absent at pretreatment, or reemerged during treatment, having been present at pre-treatment (baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
- time origin
- From first dose of study drug up to approximately 2 years 4 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety analysis set included all participants who received at least 1 dose of either 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
- NCT03245450
- outcome key
- om-0003
- source section id
- NCT03245450-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Serious Adverse Event (SAE)
- endpoint definition
- SAE was defined as any untoward medical occurrence at any dose if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.
- time origin
- Up to approximately 2 years and 4 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Safety analysis set included all participants who received at least 1 dose of either 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
- NCT03245450
- outcome key
- om-0004
- source section id
- NCT03245450-om-0004
- source outcome index
- 4
- endpoint
- Phase 1, Cmax: Maximum Observed Plasma Concentration of Eribulin, Irinotecan and Its Active Metabolite SN-38
- endpoint definition
- Phase 1, Cmax: Maximum Observed Plasma Concentration of Eribulin, Irinotecan and Its Active Metabolite SN-38
- time origin
- For eribulin, Cycle 1 Day 1: 0-120 hours post-eribulin infusion; For irinotecan and its metabolite, Cycle 1 Day 1: 0-24 hours post-irinotecan infusion (cycle length=21 days)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PK analysis set included participants who had documented dosing history and at least one post-dosing quantifiable drug concentration.
- 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
- NCT03245450
- outcome key
- om-0005
- source section id
- NCT03245450-om-0005
- source outcome index
- 5
- endpoint
- Phase 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Eribulin, Irinotecan and Its Active Metabolite SN-38
- endpoint definition
- Phase 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Eribulin, Irinotecan and Its Active Metabolite SN-38
- time origin
- For eribulin, Cycle 1 Day 1: 0-120 hours post-eribulin infusion; For irinotecan and its metabolite, Cycle 1 Day 1: 0-24 hours post-irinotecan infusion (cycle length=21 days)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PK analysis set included participants who had documented dosing history and at least one post-dosing quantifiable drug concentration.
- 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
- NCT03245450
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase 1: All Participants
- regimen
- All participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2 or 40 mg/m\^2 intravenous infusion on Days 1 to 5 (schedule A) and irinotecan hydrochloride 100 mg/m\^2 or 125 mg/m\^2 intravenous infusion on Days 1 and 8 (schedule B) in 21-day treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- regimen
- Participants with RMS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- regimen
- Participants with NRSTS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- regimen
- Participants with EWS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2
- regimen
- Participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- regimen
- Participants received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2
- regimen
- Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 100 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2
- regimen
- Participants received eribulin mesilate 1.4 mg/m\^2 and irinotecan hydrochloride 125 mg/m\^2 intravenous infusion on Days 1 and 8 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0002#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0002
- arm key
- OG004
- arm label
- Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- regimen
- Participants with RMS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0002#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0002
- arm key
- OG005
- arm label
- Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- regimen
- Participants with NRSTS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0002#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0002
- arm key
- OG006
- arm label
- Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- regimen
- Participants with EWS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0002#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2
- regimen
- Participants received eribulin mesilate 1.4 mg/m\^2 intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 20 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03245450-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-ewing-sarcoma
- nct id
- NCT03245450
- harm key
- EG000
- source section id
- NCT03245450-ae
- event group key
- EG000
- event group label
- Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 20 mg/m^2
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- From first dose of study drug up to approximately 2 year 4 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
- NCT03245450
- harm key
- EG001
- source section id
- NCT03245450-ae
- event group key
- EG001
- event group label
- Phase 1: Schedule A, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- serious affected
- 3
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- From first dose of study drug up to approximately 2 year 4 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
- NCT03245450
- harm key
- EG002
- source section id
- NCT03245450-ae
- event group key
- EG002
- event group label
- Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 100 mg/m^2
- serious affected
- 0
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- From first dose of study drug up to approximately 2 year 4 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
- NCT03245450
- harm key
- EG003
- source section id
- NCT03245450-ae
- event group key
- EG003
- event group label
- Phase 1: Schedule B, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 125 mg/m^2
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- From first dose of study drug up to approximately 2 year 4 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
- NCT03245450
- harm key
- EG004
- source section id
- NCT03245450-ae
- event group key
- EG004
- event group label
- Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- serious affected
- 5
- serious at risk
- 9
- other affected
- 9
- other at risk
- 9
- frequency threshold
- 0
- collection period
- From first dose of study drug up to approximately 2 year 4 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
- NCT03245450
- harm key
- EG005
- source section id
- NCT03245450-ae
- event group key
- EG005
- event group label
- Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- serious affected
- 4
- serious at risk
- 9
- other affected
- 9
- other at risk
- 9
- frequency threshold
- 0
- collection period
- From first dose of study drug up to approximately 2 year 4 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
- NCT03245450
- harm key
- EG006
- source section id
- NCT03245450-ae
- event group key
- EG006
- event group label
- Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- serious affected
- 3
- serious at risk
- 9
- other affected
- 9
- other at risk
- 9
- frequency threshold
- 0
- collection period
- From first dose of study drug up to approximately 2 year 4 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