Trial · NCT03245151
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
NCT03245151, Phase 1, Phase 2, Completed, Eisai Inc.; results first posted 2023-08-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors. Trials, record NCT03245151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03245151
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
- NCT number
- NCT03245151
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Recurrent and Refractory Solid Tumors
- Interventions
- Lenvatinib, Everolimus
- First posted
- 2017-08-10
- Last updated
- 2023-08-30
- Results first posted
- 2023-08-30
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus | 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. |
| Primary | Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Everolimus | 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. |
| Primary | Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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. |
| Primary | Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE) | 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. |
| Primary | Phase 2: Objective Response Rate (ORR) at Week 16 | Week 16 | 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 least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 1: Objective Response Rate (ORR) | 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. |
| Secondary | Phase 2: Objective Response Rate (ORR) | 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. |
| Secondary | Phase 1: Disease Control Rate (DCR) | 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 sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Phase 2: Disease Control Rate (DCR) | 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 diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
| Secondary | Phase 1: Clinical Benefit Rate (CBR) | 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 diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus | Cycle 1 (Each cycle was of 28 days) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | milligram per square meter (mg/m^2) | NUMBER |
| PRIMARY | Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Everolimus | Cycle 1 (Each cycle was of 28 days) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | mg/m^2 | NUMBER |
| PRIMARY | Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE) | From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months) | SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Objective Response Rate (ORR) at Week 16 | Week 16 | Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Objective Response Rate (ORR) | 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) | SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus). Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Objective Response Rate (ORR) | 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) | Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Disease Control Rate (DCR) | From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months) | SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus). | percentage of participants | NUMBER |
| SECONDARY | Phase 2: Disease Control Rate (DCR) | From first dose of study drug until PD or death, whichever occurred first (up to 6.5 months) | Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease. | percentage of participants | NUMBER |
| SECONDARY | Phase 1: Clinical Benefit Rate (CBR) | From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months) | SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus). | percentage of participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus | Phase 1: Lenvatinib + Everolimus (All Participants) | 11 | milligram per square meter (mg/m^2) | ||
| Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Everolimus | Phase 1: Lenvatinib + Everolimus (All Participants) | 11 | mg/m^2 | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 18 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE) | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 2 | Participants | ||
| Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE) | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 12 | Participants | ||
| Phase 2: Objective Response Rate (ORR) at Week 16 | Phase 2: Cohort 1, Ewing Sarcoma | 0.0 | 95% Confidence Interval 0.0 | percentage of participants | |
| Phase 2: Objective Response Rate (ORR) at Week 16 | Phase 2: Cohort 2, Rhabdomyosarcoma | 10.0 | 95% Confidence Interval 1.2 | percentage of participants | |
| Phase 2: Objective Response Rate (ORR) at Week 16 | Phase 2: Cohort 3, HGG | 0 | 95% Confidence Interval 0.0 | percentage of participants | |
| Phase 1: Objective Response Rate (ORR) | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 0.0 | 95% Confidence Interval 0.0 | percentage of participants |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 | |
| Overall Study | STARTED | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 18 | |
| Overall Study | STARTED | Phase 2: Cohort 1, Ewing Sarcoma | 10 | |
| Overall Study | STARTED | Phase 2: Cohort 2, Rhabdomyosarcoma | 20 | |
| Overall Study | STARTED | Phase 2: Cohort 3, HGG | 11 | |
| Overall Study | COMPLETED | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 0 | |
| Overall Study | COMPLETED | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 3 | |
| Overall Study | COMPLETED | Phase 2: Cohort 1, Ewing Sarcoma | 1 | |
| Overall Study | COMPLETED | Phase 2: Cohort 2, Rhabdomyosarcoma | 2 | |
| Overall Study | COMPLETED | Phase 2: Cohort 3, HGG | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events1,250
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 2 | 5 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 6 | 18 | 16 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Cohort 1, Ewing Sarcoma | 5 | 10 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Cohort 2, Rhabdomyosarcoma | 7 | 20 | 10 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Cohort 3, HGG | 1 | 11 | 5 |
| other | Sinus bradycardia | Cardiac disorders | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 1 | 5 | 1 |
| other | Sinus bradycardia | Cardiac disorders | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 0 | 18 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Phase 2: Cohort 1, Ewing Sarcoma | 0 | 10 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Phase 2: Cohort 2, Rhabdomyosarcoma | 3 | 20 | 3 |
| other | Sinus bradycardia | Cardiac disorders | Phase 2: Cohort 3, HGG | 0 | 11 | 0 |
1 to 10 of 1,250Source ClinicalTrials.gov
See all 1,250 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 4 | 5 |
| Total, all-cause mortality | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 14 | 18 |
| Total, all-cause mortality | Phase 2: Cohort 1, Ewing Sarcoma | 9 | 10 |
| Total, all-cause mortality | Phase 2: Cohort 2, Rhabdomyosarcoma | 17 | 20 |
| Total, all-cause mortality | Phase 2: Cohort 3, HGG | 8 | 11 |
| Total, other adverse events | Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 | 5 |
| Total, other adverse events | Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 18 | 18 |
| Total, other adverse events | Phase 2: Cohort 1, Ewing Sarcoma | 10 | 10 |
| Total, other adverse events | Phase 2: Cohort 2, Rhabdomyosarcoma | 19 | 20 |
| Total, other adverse events | Phase 2: Cohort 3, HGG | 11 | 11 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40313040 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 vs Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2: Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE) | Trial comparisons |
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 vs Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2: Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03245151
GET https://conductscience.org/api/trials/v1/NCT03245151/results?page=2