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← recurrent Osteosarcoma

NCT02432274 · STUDY IN CONTEXT

Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

RD was defined as the dose that had a dose limiting toxicity (DLT) rate closest to the targeted 20% rate. DLT was an adverse drug reaction and was assessed according to common terminology criteria for adverse events (CTCAE) version (v) 4.03 defined as 1) Grade 4 neutropenia for greater than or equal to (\>=) 7 days, 2) Grade \>=3 thrombocytopenia with bleeding, or lasting greater than (\>) 7 days, 3) Grade \>=3 febrile neutropenia, 4) Next course of chemotherapy delayed for \>=7 days, 5) Grade \>=3 non-hematologic toxicity persisting \>7 days optimal supportive care, 6) Grade 4 hypertension, confirmed systolic or diastolic blood pressure \>25 millimeters of mercury (mmHg) above the 95th percentile for age, or an elevated diastolic blood pressure (that is, \>95th percentile for age) not controlled by a single antihypertensive medication within 14 days of use, 7) Grade 3 proteinuria, 8) Any recurrent Grade 2 non-hematological toxicity requiring \>=2 interruption and dose reductions.

Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.

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primary · POSTED

OR was defined as participants with best overall response (BOR) of CR or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. For OR, the BOR was defined as the best response (CR or PR for \>4 weeks) recorded from the start of the treatment until PD or death whichever occurred first. CR was defined as the 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 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as 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.

Full analysis set included all enrolled participants who did not fail study screening.

→

primary · POSTED

BOR was defined as the best response of CR or PR for \>4 weeks or SD for \>=7 weeks recorded from the start of the treatment until PD or death, whichever occurred first based on RECIST v1.1. 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 was defined as 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.

Full analysis set included all enrolled participants who did not fail study screening.

→

primary · POSTED

Progression free survival at Month 4 (PFS-4) rate was defined as the percentage of participants who were alive and without PD at Month 4 after the first dose of study drug, based on RECIST v1.1, using a binomial proportion with corresponding 95% confidence interval (CI). PD: \>= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of \>=5 mm. Appearance of \>=1 new lesions also considered PD.

PFS-4 evaluable set included all participants treated with study drug for at least 4 months or those who died or radiologically progressed within 4 months after first dose, or received anticancer treatment within 4 months after first dose.

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primary · POSTED

RD of lenvatinib when given in combination with ifosfamide and etoposide was defined as dose that resulted in no more than 1 DLT per 6 participants,or hematologic DLT in 1 participant and nonhematologic DLT in another participant per 6 participants,upon repeating same dose level.DLT was adverse drug reaction and assessed per CTCAE v4.03 defined as 1)Grade 4 neutropenia for \>=10 days,2)Grade \>=3 thrombocytopenia with bleeding,or lasting \>=10 days,3)Grade \>=3 febrile neutropenia lasting \>=7 days,4)Next course of chemotherapy delayed for \>=7 days,5)Grade \>=3 nonhematologic toxicity persisting \>7 days despite optimal supportive care,6)Grade 4 hypertension,confirmed systolic or diastolic blood pressure \>25 mmHg above 95th percentile for age,or elevated diastolic blood pressure(\>95th percentile for age)not controlled by single antihypertensive medication within 14 days use,7)Grade 3 proteinuria,8)Any recurrent Grade 2 nonhematological toxicity requiring \>=2 interruption and dose reductions.

Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.

→

secondary · POSTED

BOR: best response of CR or PR for \>4 weeks or SD for \>=7 weeks from first dose, recorded from start of treatment until PD or death, whichever occurred first based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have reduction in their short axis \<10 mm. PR: at least 30% decrease in 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 was defined as: 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. Not evaluable (NE) means BOR of NE or SD of \<7 weeks duration. Unknown means no data were available on the case report form.

Full analysis set included all enrolled participants who did not fail study screening. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT02432274
qol key
qol-0018
source section id
NCT02432274-om-0018
source outcome index
18
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
measure definition
Serum biomarkers included Fibroblast Growth Factor (FGF) 19, FGF 21, Vascular Endothelial Growth Factor (VEGF). In this outcome measure, percent change from baseline in serum biomarkers level per "PFS-4, Yes" and "PFS-4, No" have been reported. As per assessment of investigator based on RECIST v1.1, "PFS-4, Yes"= participants evaluable for PFS-4 month and alive and without PD at 4 months from the first dose, "PFS-4, No"=participants evaluable for PFS-4 month and not alive or with PD at 4 months from the first dose.
time frame
Cohort 2B: Baseline, Cycle 2-3 Day 1 (Duration of each cycle=28 days); Cohort 3B: Baseline, Cycle 2 Day 1, Cycle 4 Day 1 (Duration of each cycle=21 days)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
PFS-4 evaluable set: all participants treated with study drug for at least 4 months or those who died or radiologically progressed within 4 months after first dose or received anticancer treatment within 4 months after first dose. "N": participants evaluable for this measure. "n": participants who were evaluable for this measure for specific rows.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-osteosarcoma-recurrent-90acb206
nct id
NCT02432274
trial label
Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
9
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0000
    source section id
    NCT02432274-om-0000
    source outcome index
    0
    endpoint
    Cohort 1: Recommended Dose (RD) of Lenvatinib
    endpoint definition
    RD was defined as the dose that had a dose limiting toxicity (DLT) rate closest to the targeted 20% rate. DLT was an adverse drug reaction and was assessed according to common terminology criteria for adverse events (CTCAE) version (v) 4.03 defined as 1) Grade 4 neutropenia for greater than or equal to (\>=) 7 days, 2) Grade \>=3 thrombocytopenia with bleeding, or lasting greater than (\>) 7 days, 3) Grade \>=3 febrile neutropenia, 4) Next course of chemotherapy delayed for \>=7 days, 5) Grade \>=3 non-hematologic toxicity persisting \>7 days optimal supportive care, 6) Grade 4 hypertension, confirmed systolic or diastolic blood pressure \>25 millimeters of mercury (mmHg) above the 95th percentile for age, or an elevated diastolic blood pressure (that is, \>95th percentile for age) not controlled by a single antihypertensive medication within 14 days of use, 7) Grade 3 proteinuria, 8) Any recurrent Grade 2 non-hematological toxicity requiring \>=2 interruption and dose reductions.
    time origin
    Cycle 1 (28 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0001
    source section id
    NCT02432274-om-0001
    source outcome index
    1
    endpoint
    Cohort 2A: Number of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
    endpoint definition
    OR was defined as participants with best overall response (BOR) of CR or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. For OR, the BOR was defined as the best response (CR or PR for \>4 weeks) recorded from the start of the treatment until PD or death whichever occurred first. CR was defined as the 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 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as 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.
    time origin
    From date of first dose of study drug until first documentation of PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set included all enrolled participants who did not fail study screening.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0002
    source section id
    NCT02432274-om-0002
    source outcome index
    2
    endpoint
    Cohort 2A: Number of Participants With Best Overall Response (BOR)
    endpoint definition
    BOR was defined as the best response of CR or PR for \>4 weeks or SD for \>=7 weeks recorded from the start of the treatment until PD or death, whichever occurred first based on RECIST v1.1. 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 was defined as 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.
    time origin
    From first dose of study drug until PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set included all enrolled participants who did not fail study screening.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0003
    source section id
    NCT02432274-om-0003
    source outcome index
    3
    endpoint
    Cohorts 2B and 3B: Progression-free Survival (PFS) Rate at Month 4
    endpoint definition
    Progression free survival at Month 4 (PFS-4) rate was defined as the percentage of participants who were alive and without PD at Month 4 after the first dose of study drug, based on RECIST v1.1, using a binomial proportion with corresponding 95% confidence interval (CI). PD: \>= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of \>=5 mm. Appearance of \>=1 new lesions also considered PD.
    time origin
    At Month 4
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PFS-4 evaluable set included all participants treated with study drug for at least 4 months or those who died or radiologically progressed within 4 months after first dose, or received anticancer treatment within 4 months after first dose.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0004
    source section id
    NCT02432274-om-0004
    source outcome index
    4
    endpoint
    Cohort 3A: Recommended Dose (RD) of Lenvatinib When Given in Combination With Etoposide and Ifosfamide
    endpoint definition
    RD of lenvatinib when given in combination with ifosfamide and etoposide was defined as dose that resulted in no more than 1 DLT per 6 participants,or hematologic DLT in 1 participant and nonhematologic DLT in another participant per 6 participants,upon repeating same dose level.DLT was adverse drug reaction and assessed per CTCAE v4.03 defined as 1)Grade 4 neutropenia for \>=10 days,2)Grade \>=3 thrombocytopenia with bleeding,or lasting \>=10 days,3)Grade \>=3 febrile neutropenia lasting \>=7 days,4)Next course of chemotherapy delayed for \>=7 days,5)Grade \>=3 nonhematologic toxicity persisting \>7 days despite optimal supportive care,6)Grade 4 hypertension,confirmed systolic or diastolic blood pressure \>25 mmHg above 95th percentile for age,or elevated diastolic blood pressure(\>95th percentile for age)not controlled by single antihypertensive medication within 14 days use,7)Grade 3 proteinuria,8)Any recurrent Grade 2 nonhematological toxicity requiring \>=2 interruption and dose reductions.
    time origin
    Cycle 1 (21 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0005
    source section id
    NCT02432274-om-0005
    source outcome index
    5
    endpoint
    Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
    endpoint definition
    BOR: best response of CR or PR for \>4 weeks or SD for \>=7 weeks from first dose, recorded from start of treatment until PD or death, whichever occurred first based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have reduction in their short axis \<10 mm. PR: at least 30% decrease in 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 was defined as: 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. Not evaluable (NE) means BOR of NE or SD of \<7 weeks duration. Unknown means no data were available on the case report form.
    time origin
    From date of first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full analysis set included all enrolled participants who did not fail study screening. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1: All Participants
    regimen
    Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
    analyzed count
    23
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
    regimen
    Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
    regimen
    Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
    regimen
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
    analyzed count
    28
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
    regimen
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
    analyzed count
    15
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0003#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Cohort 3A: All Participants
    regimen
    Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1) or 14 mg/m\^2, administered per BSA with daily dose capped at 24 mg/day as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle, in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
    analyzed count
    22
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0004#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
    regimen
    Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0005#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
    regimen
    Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0005#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0005
    arm key
    OG002
    arm label
    Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
    regimen
    Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0005#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0005
    arm key
    OG003
    arm label
    Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
    regimen
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
    analyzed count
    30
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0005#groups/OG003
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0005
    arm key
    OG004
    arm label
    Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
    regimen
    Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0005#groups/OG004
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    outcome key
    om-0005
    arm key
    OG005
    arm label
    Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
    regimen
    Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
    analyzed count
    14
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02432274-om-0005#groups/OG005
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG000
    source section id
    NCT02432274-ae
    event group key
    EG000
    event group label
    Lenvatinib 5 mg/m^2
    serious affected
    0
    serious at risk
    2
    other affected
    2
    other at risk
    2
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG001
    source section id
    NCT02432274-ae
    event group key
    EG001
    event group label
    Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
    serious affected
    3
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG002
    source section id
    NCT02432274-ae
    event group key
    EG002
    event group label
    Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
    serious affected
    7
    serious at risk
    11
    other affected
    11
    other at risk
    11
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG003
    source section id
    NCT02432274-ae
    event group key
    EG003
    event group label
    Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
    serious affected
    5
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG004
    source section id
    NCT02432274-ae
    event group key
    EG004
    event group label
    Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
    serious affected
    1
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG005
    source section id
    NCT02432274-ae
    event group key
    EG005
    event group label
    Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
    serious affected
    21
    serious at risk
    31
    other affected
    29
    other at risk
    31
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG006
    source section id
    NCT02432274-ae
    event group key
    EG006
    event group label
    Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
    serious affected
    7
    serious at risk
    11
    other affected
    11
    other at risk
    11
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG007
    source section id
    NCT02432274-ae
    event group key
    EG007
    event group label
    Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
    serious affected
    9
    serious at risk
    11
    other affected
    11
    other at risk
    11
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    harm key
    EG008
    source section id
    NCT02432274-ae
    event group key
    EG008
    event group label
    Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
    serious affected
    16
    serious at risk
    20
    other affected
    20
    other at risk
    20
    frequency threshold
    0
    collection period
    From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
    event definition
    Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-osteosarcoma-recurrent-90acb206
    nct id
    NCT02432274
    qol key
    qol-0018
    source section id
    NCT02432274-om-0018
    source outcome index
    18
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
    measure definition
    Serum biomarkers included Fibroblast Growth Factor (FGF) 19, FGF 21, Vascular Endothelial Growth Factor (VEGF). In this outcome measure, percent change from baseline in serum biomarkers level per "PFS-4, Yes" and "PFS-4, No" have been reported. As per assessment of investigator based on RECIST v1.1, "PFS-4, Yes"= participants evaluable for PFS-4 month and alive and without PD at 4 months from the first dose, "PFS-4, No"=participants evaluable for PFS-4 month and not alive or with PD at 4 months from the first dose.
    time frame
    Cohort 2B: Baseline, Cycle 2-3 Day 1 (Duration of each cycle=28 days); Cohort 3B: Baseline, Cycle 2 Day 1, Cycle 4 Day 1 (Duration of each cycle=21 days)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    PFS-4 evaluable set: all participants treated with study drug for at least 4 months or those who died or radiologically progressed within 4 months after first dose or received anticancer treatment within 4 months after first dose. "N": participants evaluable for this measure. "n": participants who were evaluable for this measure for specific rows.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice