Adults 2 to 21, any sex, with Recurrent and Refractory Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With EverolimusPrimary· Cycle 1 (Each cycle was of 28 days)
MTD was defined as the highest dose level at which no more than 1/6 participants experienced a dose limiting toxicity (DLTs), with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. DLT was graded according to common terminology criteria for adverse events (CTCAE) version 4.03.
Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With EverolimusPrimary· Cycle 1 (Each cycle was of 28 days)
The RP2D of lenvatinib in combination with everolimus was determined by Dose Escalation Committee (DEC) based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v4.03.
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)Primary· From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months)
A TEAE was defined as an adverse event that emerged during treatment, having been absent at pretreatment or reemerged during treatment, having been present at pretreatment but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the adverse event is continuous. An adverse event was defined as any untoward medical occurrence in a participant administered an investigational product.
Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)Primary· From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months)
A TESAE was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria. An adverse event was defined as any untoward medical occurrence in a participant administered an investigational product.
ORR at Week 16 was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at Week 16 based on investigator assessment according to response evaluation criteria in solid tumors (RECIST) version 1.1 for non-HGG cohorts and response assessment in neuro-oncology (RANO) for HGG cohort. CR was defined as disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeter (mm). PR was defined as at
Group
Value
95% CI
Phase 2: Cohort 1, Ewing Sarcoma
0.0
0.0 – 30.8
Phase 2: Cohort 2, Rhabdomyosarcoma
10.0
1.2 – 31.7
Phase 2: Cohort 3, HGG
0
0.0 – 30.8
Phase 1: Objective Response Rate (ORR)Secondary· From the date of the first dose of study drug to the date of first documentation of disease progression or death, whichever occurred first (up to 16.5 months)
ORR was defined as the percentage of participants with BOR of CR or PR based on investigator assessment according to RECIST version 1.1 for non-HGG cohorts and RANO for HGG cohort. CR was defined as disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters.
Phase 2: Objective Response Rate (ORR)Secondary· From the date of the first dose of study drug to the date of first documentation of disease progression or death, which ever occurred first (up to 6.5 months)
ORR was defined as the percentage of participants with BOR of CR or PR based on investigator assessment according to RECIST version 1.1 for non-HGG cohorts and RANO for HGG cohort. CR was defined as disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters.
Group
Value
95% CI
Phase 2: Cohort 1, Ewing Sarcoma
0.0
0.0 – 30.8
Phase 2: Cohort 2, Rhabdomyosarcoma
10.0
1.2 – 31.7
Phase 2: Cohort 3, HGG
0.0
0.0 – 30.8
Phase 1: Disease Control Rate (DCR)Secondary· From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months)
DCR was defined as percentage of participants with a confirmed CR, PR, or stable disease (SD) (SD duration \>=7 weeks since the first dose of study treatment) divided by number of participants in analysis set. DCR was assessed by an investigator based on RECIST v1.1 for non-HGG participants or RANO for HGG participants. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline su
Phase 2: Disease Control Rate (DCR)Secondary· From first dose of study drug until PD or death, whichever occurred first (up to 6.5 months)
DCR was defined as percentage of participants with confirmed CR, PR, or SD (SD duration greater than or equal to \[\>=\] 7 weeks since first dose of study treatment) divided by number of participants in analysis set. DCR was assessed by investigator based on RECIST v1.1 for non-HGG cohorts or RANO for HGG cohort. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diame
Group
Value
95% CI
Phase 2: Cohort 1, Ewing Sarcoma
40.0
12.2 – 73.8
Phase 2: Cohort 2, Rhabdomyosarcoma
40.0
19.1 – 63.9
Phase 2: Cohort 3, HGG
30.0
6.7 – 65.2
Phase 1: Clinical Benefit Rate (CBR)Secondary· From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months)
CBR was defined as percentage of participants who had BOR of CR, PR, or durable SD (SD duration \>=23 weeks since the first dose of study treatment) divided by number of participants in analysis set. CBR was assessed by an investigator based on RECIST v1.1 for non-HGG participants or RANO for HGG participants. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameter
Phase 2: Clinical Benefit Rate (CBR)Secondary· From first dose of study drug until PD or death, whichever occurred first (up to 6.5 months)
CBR was defined as percentage of participants who had BOR of CR, PR, or durable SD (SD duration \>=23 weeks since the first dose of study treatment) divided by number of participants in analysis set. CBR was assessed by an investigator based on RECIST v1.1 for non-HGG cohorts or RANO for HGG cohort. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neit
Group
Value
95% CI
Phase 2: Cohort 1, Ewing Sarcoma
20.0
2.5 – 55.6
Phase 2: Cohort 2, Rhabdomyosarcoma
10.0
1.2 – 31.7
Phase 2: Cohort 3, HGG
0.0
0.0 – 30.8
Phase 2: Duration of Response (DOR)Secondary· From date of the first observation of CR or PR until the date of first observation of progression or date of death (up to 6.5 months)
DOR was defined as the time (in months) from the date of first observation of confirmed response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1 for non-HGG cohorts and RANO for HGG cohort, or date of death, whatever the cause. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was
Group
Value
95% CI
Phase 2: Cohort 2, Rhabdomyosarcoma
2.4
2.1 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with everolimus once daily to pediatric participants with recurrent/refractory solid tumors. Phase 2, utilizing Simon's optimal 2-stage design, will be conducted to estimate the antitumor activity of lenvatinib in combination with everolimus in pediatric participants with selected recurrent/refractory solid tumors including Ewing sarcoma, rhabdomyosarcoma, and high grade glioma (HGG) using objective response rate (ORR) at Week 16 as the outcome measure.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer
· Phase 3
· not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence
· Phase 3
· not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin
· Phase 2
· not yet recruiting
NCT07493668 — Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy
· Phase 2
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 30 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03245151.