NCT02432274 is a Phase 1, PHASE2 clinical trial of Lenvatinib in Tumors, sponsored by Eisai Limited.

Who is sponsoring NCT02432274?

NCT02432274 is sponsored by Eisai Limited.

What drugs are being tested in NCT02432274?

Interventions in NCT02432274: Lenvatinib, Lenvatinib, Lenvatinib, Lenvatinib, Lenvatinib, Ifosfamide, Etoposide, Ifosfamide, Etoposide.

What condition does NCT02432274 study?

NCT02432274 studies Tumors, Solid Malignant Tumors, Osteosarcoma, Differentiated Thyroid Cancer (DTC).

Is NCT02432274 still recruiting?

NCT02432274 is currently completed. Last updated 11 July 2023.

Are results published for NCT02432274?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-07-11 · How we verify

NCT02432274

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Results posted Last updated 11 July 2023

What this trial tests

Phase 1, PHASE2 trial testing Lenvatinib in Tumors in 117 participants. Completed in 20 July 2022.

Timeline

29 December 2014

Primary endpoint
18 July 2019

20 July 2022

Quick facts

Lead sponsor	Eisai Limited
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	117
Start date	29 December 2014
Primary completion	18 July 2019
Estimated completion	20 July 2022
Sites	19 locations across France, Italy, United Kingdom, Germany, United States, Spain

Drugs / interventions tested

Lenvatinib (LENVATINIB) — full drug profile →
Lenvatinib (LENVATINIB) — full drug profile →
Lenvatinib (LENVATINIB) — full drug profile →
Lenvatinib (LENVATINIB) — full drug profile →
Lenvatinib (LENVATINIB) — full drug profile →
Ifosfamide (IFOSFAMIDE) — full drug profile →
Etoposide (etoposide) — full drug profile →
Ifosfamide (IFOSFAMIDE) — full drug profile →
Etoposide (etoposide) — full drug profile →

Conditions studied

Tumors — all drugs for Tumors →
Solid Malignant Tumors — all drugs for Solid Malignant Tumors →
Osteosarcoma — all drugs for Osteosarcoma →
Differentiated Thyroid Cancer (DTC) — all drugs for Differentiated Thyroid Cancer (DTC) →

Sponsor

Eisai Limited — full company profile →

Who can join

Adults 2 to 25, any sex, with Tumors or Solid Malignant 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.

Cohort 1: Recommended Dose (RD) of Lenvatinib Primary · Cycle 1 (28 days)

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, c

Group	Value	95% CI
Cohort 1: All Participants	14

Cohort 2A: Number of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR) Primary · 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)

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% decreas

Group	Value	95% CI
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	1

Cohort 2A: Number of Participants With Best Overall Response (BOR) Primary · From first dose of study drug until PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)

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

Complete Response

Group	Value	95% CI
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	0

Partial Response

Group	Value	95% CI
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	1

Stable Disease

Group	Value	95% CI
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	0

Cohorts 2B and 3B: Progression-free Survival (PFS) Rate at Month 4 Primary · At Month 4

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.

Group	Value	95% CI
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	32.1	15.9 – 52.4
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	66.7	38.4 – 88.2

Cohort 3A: Recommended Dose (RD) of Lenvatinib When Given in Combination With Etoposide and Ifosfamide Primary · Cycle 1 (21 days)

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 persist

Group	Value	95% CI
Cohort 3A: All Participants	14

Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR) Secondary · 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)

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

Complete Response

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	0
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	0
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	0
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	0
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	0
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	0
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	0

Partial Response

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	0
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	0
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	0
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	2
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	2
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	0
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	3

Stable Disease

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	2
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	5
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	4
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	13
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	3
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	10
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	9

Progressive Disease

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	1
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	2
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	4
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	12
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	2
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	2
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	4

Not Evaluable or Unknown

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	0
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	2
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	2
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	3
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	0
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	2
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	2

Cohorts 1, 2B, 3A, and 3B: Objective Response Rate (ORR) Secondary · 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)

ORR was defined as the percentage of participants with a BOR of CR or PR for \>4 weeks or SD for \>=7 weeks as assessed by investigator based on RECIST v1.1, recorded from start of study 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 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. 95% CI of the ORR were calculated ac

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	0	0.0 – 70.8
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	0	0.0 – 33.6
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	0	0.0 – 30.8
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	6.7	0.8 – 22.1
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	28.6	3.7 – 71.0
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	0	0.0 – 23.2
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	16.7	3.6 – 41.4

Cohorts 1, 2A, 2B, 3A and 3B: Duration of Response (DOR) Secondary · First documentation of CR/PR until first documentation of PD (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

DOR was defined as time in months from the first documentation confirmed CR or PR until the first documentation of confirmed PD as assessed by investigator 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. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the s

Group	Value	95% CI
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	1.9	NA – NA
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	4.6	NA – NA
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	NA	NA – NA
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	NA	NA – NA

Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Who Experienced Disease Control Secondary · From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

Participants were defined as having disease control if they had a BOR of CR or PR for \>4 weeks, or SD (minimum duration from first dose to SD \>=7 weeks) or if participants had a BOR of CR or Non-CR/Non-PD (minimum duration from first dose to Non-CR/Non-PD \>=7 weeks) per RECIST v1.1, recorded from first dose until PD or death whichever occurred first. CR: disappearance of all target/non-target lesions (non-lymph nodes). All pathological lymph nodes (target/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 refere

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	2
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	5
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	5
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	1
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	16
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	5
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	11
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	14

Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Experienced Clinical Benefit Secondary · From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

Participants were defined as having clinical benefit if they had a BOR of CR or PR for \>4 weeks or durable SD (lasting \>=23 weeks) or if participants had a BOR of CR or durable Non-CR/Non-PD (lasting \>=23 weeks) as per RECIST v1.1, recorded from first dose until PD or death whichever occurred first. CR: disappearance of all target/non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target/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

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	0
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	3
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	4
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	1
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	7
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	4
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	5
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	8

Cohorts 1, 2A, 2B, 3A and 3B: Progression-free Survival (PFS) Secondary · From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

PFS was defined as the time (in months) from the date of first dose of study drug to the date of first documentation of PD or date of death, whichever occurred first, based on RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions. 95% CI of median were calculated according to Brookmeyer and Crowley method.

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	3.7	0.5 – 5.0
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	6.3	0.6 – 10.6
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	5.5	1.4 – 11.3
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	5.5	NA – NA
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	3.0	1.8 – 5.4
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	7.1	2.1 – NA
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	12.0	11.1 – 16.1
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	6.9	4.2 – NA

Cohorts 1, 2A, 2B, 3A and 3B: Time to Progression (TTP) Secondary · From first dose of study drug until PD (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

TTP was defined as the time from the date of first dose of study drug to the date of first documentation of PD based on RECIST 1.1. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the baseline SOD of target lesions. 95% CI of median were calculated according to Brookmeyer and Crowley method.

Group	Value	95% CI
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2	3.7	0.5 – 5.0
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2	6.3	0.6 – 10.6
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2	5.5	1.4 – 11.3
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2	5.5	NA – NA
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2	3.0	1.8 – 5.4
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2	7.1	2.1 – NA
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2	12.0	11.1 – 16.1
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2	6.9	4.2 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lenvatinib 5 mg/m^2

Serious: 0/2 (0%)

Deaths: 0/2

Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2

Serious: 3/5 (60%)

Deaths: 2/5

Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2

Serious: 7/11 (64%)

Deaths: 7/11

Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2

Serious: 5/7 (71%)

Deaths: 6/7

Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2

Serious: 1/1 (100%)

Deaths: 0/1

Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2

Serious: 21/31 (68%)

Deaths: 27/31

Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2

Serious: 7/11 (64%)

Deaths: 10/11

Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2

Serious: 9/11 (82%)

Deaths: 6/11

Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2

Serious: 16/20 (80%)

Deaths: 14/20

Serious adverse events (91 terms)

Reaction	System	Lenvatinib 5 mg/m^2	Cohort 1, Single-agent Dos…	Cohort 1, Single-agent Dos…	Cohort 1, Single-agent Dos…	Cohort 2A, Single-agent Ex…	Cohort2B,Single-agentExpan…	Cohort 3A, Combination Dos…	Cohort 3A, Combination Dos…	Cohort 3B, Combination Exp…
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—
Disseminated intravascular coagulation	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Enterocolitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Gait disturbance	General disorders	—	—	—	—	—	—	—	—	—

Other adverse events (371 terms — click to expand)

Reaction	System	Lenvatinib 5 mg/m^2	Cohort 1, Single-agent Dos…	Cohort 1, Single-agent Dos…	Cohort 1, Single-agent Dos…	Cohort 2A, Single-agent Ex…	Cohort2B,Single-agentExpan…	Cohort 3A, Combination Dos…	Cohort 3A, Combination Dos…	Cohort 3B, Combination Exp…
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Blood thyroid stimulating hormone increased	Investigations	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Febrile neutropenia, White blood cell count decreased, Platelet count decreased, Back pain, Pneumothorax, Neutrophil count decreased, Cancer pain, Tumour pain.

Data from ClinicalTrials.gov NCT02432274 adverse events section.

Sponsor's own description

This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib as single-agent, and in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed solid malignancies including differentiated thyroid carcinoma (single agent lenvatinib) and osteosarcoma (single agent and combination lenvatinib).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cancer-associated fibroblasts: from basic science to anticancer therapy.
Yang D, Liu J, Qian H, Zhuang Q. · · 2023 · cited 389× · PMID 37394578 · DOI 10.1038/s12276-023-01013-0
Cancer-associated fibroblasts and resistance to anticancer therapies: status, mechanisms, and countermeasures.
Feng B, Wu J, Shen B, Jiang F, et al · · 2022 · cited 150× · PMID 35488263 · DOI 10.1186/s12935-022-02599-7
Pathogenesis and Current Treatment of Osteosarcoma: Perspectives for Future Therapies.
Rathore R, Van Tine BA. · · 2021 · cited 81× · PMID 33809018 · DOI 10.3390/jcm10061182
Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050): a multicentre, open-label, multicohort, phase 1/2 study.
Gaspar N, Venkatramani R, Hecker-Nolting S, Melcon SG, et al · · 2021 · cited 72× · PMID 34416158 · DOI 10.1016/s1470-2045(21)00387-9
Joint adolescent-adult early phase clinical trials to improve access to new drugs for adolescents with cancer: proposals from the multi-stakeholder platform-ACCELERATE.
Gaspar N, Marshall LV, Binner D, Herold R, et al · · 2018 · cited 61× · PMID 29351570 · DOI 10.1093/annonc/mdy002
Origin and Therapies of Osteosarcoma.
Moukengue B, Lallier M, Marchandet L, Baud'huin M, et al · · 2022 · cited 60× · PMID 35884563 · DOI 10.3390/cancers14143503
Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)<sup>☆</sup>.
Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, et al · · 2021 · cited 52× · PMID 34562750 · DOI 10.1016/j.esmoop.2021.100250
Opportunities and Challenges in Drug Development for Pediatric Cancers.
Laetsch TW, DuBois SG, Bender JG, Macy ME, et al · · 2021 · cited 45× · PMID 33277309 · DOI 10.1158/2159-8290.cd-20-0779

Verify or expand the search:

Other trials of Lenvatinib

Trials testing the same drug.

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Currently open trials in the same condition.

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Other Eisai Limited trials

Trials by the same sponsor.

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NCT05607537 — A Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of Carbon-1 · Phase 1 · completed
NCT04840927 — A Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release (TR) Tablets · Phase 1 · withdrawn
NCT04493255 — A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants · Phase 1 · completed
NCT04252846 — A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02432274 (US National Library of Medicine, public domain)
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 Limited
Last refreshed: 11 July 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/NCT02432274.

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