A Study to Compare the Efficacy and Safety of Ifosfamide and Etoposide With or Without Lenvatinib in Children, Adolescents and Young Adults With Relapsed and Refractory Osteosarcoma

A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.

Study Overview

• Status: Completed
• Conditions: Osteosarcoma
• Intervention / Treatment: Drug: Lenvatinib; Drug: Ifosfamide; Drug: Etoposide; Drug: Lenvatinib

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Camperdown, Australia
    • Chris O'Brien Lifehouse Hospital
  • Nedlands, Australia
    • Perth Childrens Hospital
  • Parkville, Australia
    • Royal Children's Hospital Melbourne
  • South Brisbane, Australia
    • Queensland Children's Hospital
  • Westmead, Australia
    • Children's Hospital at Westmead
• Austria
  • Wien, Austria
    • St. Anna Kinderspital
• Belgium
  • Gent, Belgium
    • UZ Gent
• Canada
  • Toronto, Canada
    • Hospital for Sick Children
• Czechia
  • Brno, Czechia
    • FN Brno 2 Detska Klinika
  • Prague, Czechia
    • Fakultni nemocnice v Motole
• Finland
  • Länsi-Suomen Lääni
    • Tampere, Länsi-Suomen Lääni, Finland, FI-33520
      • Tampereen yliopistollinen sairaala
• France
  • Bordeaux, France
    • Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
  • Lille, France
    • Centre Oscar Lambret
  • Lyon, France
    • Centre Leon Bérard
  • Marseille, France
    • Hopitaux de La Timone
  • Nantes, France
    • Hôpital de la mère et de l'enfant
  • Nice, France
    • Chu de Nice
  • Paris, France
    • Institut Curie
  • Paris, France
    • Hôpital Armand Trousseau
  • Strasbourg, France
    • Hopital de Hautepierre
  • Toulouse, France
    • Hopital des Enfants
  • Vandœuvre-lès-Nancy, France
    • CHRU Nancy
  • Villejuif, France
    • Institut Gustave Roussy
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
  • Hong Kong, Hong Kong
    • Hong Kong Children's Hospital
• Ireland
  • Dublin, Ireland
    • Children's Health Ireland at Crumlin
• Israel
  • Petach Tikva, Israel
    • Schneider Children's Medical Center of Israel
• Italy
  • Bologna, Italy
    • Istituti Ortopedici Rizzoli
  • Firenze, Italy
    • Azienda Ospedaliera A Meyer
  • Genova, Italy
    • Istituto Giannina Gaslini
  • Milan, Italy
    • Istituto Nazionale dei Tumori
  • Roma, Italy
    • IRCCS Ospedale Pediatrico Bambino Gesu
• Korea, Republic of
  • Goyang-si, Korea, Republic of
    • National Cancer Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital Yonsei University Health System
• Netherlands
  • Utrecht, Netherlands
    • Princess Máxima Center for Pediatric Oncology
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
  • Auckland, New Zealand
    • Starship Children's Hospital
• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, Singapore
    • KK Women's and Children's Hospital
  • Singapore, Singapore
    • National Cancer Centre
• Spain
  • Barakaldo, Spain
    • Hospital Universitario de Cruces
  • Barcelona, Spain
    • Hospital Sant Joan de Déu
  • Barcelona, Spain
    • Hospital Universitario Vall d'Hebrón
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain
    • Hospital Infantil Universitario Niño Jesús
  • Sevilla, Spain
    • Hospital Universitario Virgen Del Rocio
  • Valencia, Spain
    • Hospital Universitari i Politecnic La Fe de Valencia
• Sweden
  • Göteborg, Sweden
    • Drottning Silvias Barn Och Ungdomssjukhus
  • Lund, Sweden
    • Skånes universitetssjukhus Lund
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset Solna
• Switzerland
  • Lausanne, Switzerland
    • Centre Hospitalier Universitaire Vaudois
  • Zürich, Switzerland
    • Kinderspital Zurich - Eleonorenstiftung
• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
• United Kingdom
  • Birmingham, United Kingdom
    • Birmingham Children's Hospital
  • Bristol, United Kingdom
    • The Royal Hospital for Children
  • Glasgow, United Kingdom
    • Royal Hospital For Children
  • Leeds, United Kingdom
    • Leeds Children Hospital
  • Liverpool, United Kingdom
    • Alder Hey Children's Hospital
  • London, United Kingdom
    • UCL Cancer Institute
  • Manchester, United Kingdom
    • The Christie NHS Foundation Trust
  • Manchester, United Kingdom
    • Royal Manchester Childrens Hospital
  • Newcastle, United Kingdom
    • Royal Victoria Infirmary
  • Oxford, United Kingdom
    • John Radcliffe Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's of Alabama
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
    • San Francisco, California, United States, 94143
      • UCSF Benioff Children's Hospitals
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Childrens Hospital Colorado
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Health Care System
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of high grade osteosarcoma
2. Refractory or relapsed osteosarcoma after 1 to 2 prior lines of systemic treatments
3. Measurable or evaluable disease per RECIST 1.1.
4. Life expectancy of 12 weeks or more
5. Lansky play score greater than or equal to (>=) 50 Percent (%) or Karnofsky Performance Status score >=50%. Use Karnofsky for participants >=16 years of age and Lansky for participants less than (<)16 years of age. Participants who are unable to walk because of paralysis, but who are able to perform activities of daily living while wheelchair bound, will be considered ambulatory for the purpose of assessing the performance score
6. Adequate organ function per blood work
7. Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) >=50% at baseline as determined by echocardiography or multigated acquisition (MUGA) scan

8. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as:

   BP <95th percentile for sex, age, and height/length at screening (as per National Heart Lung and Blood Institute guidelines) and no change in antihypertensive medications within 1 week prior to Cycle 1 Day 1. Participants >18 years of age should have BP less than or equal to (<=) 150/90 millimeters of Mercury at screening and no change in antihypertensive therapy within 1 week prior to Cycle 1 Day 1

9. Washout before Cycle 1 Day 1 of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas; 4 weeks for definitive radiotherapy, 2 weeks for palliative radiotherapy; and 3 months from high-dose chemotherapy and stem cell rescue. For all other anti-cancer therapies, washout before Cycle 1 Day 1 of at least 5 half-lives (or at least 28 days, whichever is shorter). Participants must have recovered [to Grade <=1, except for alopecia, ototoxicity, and Grade <=2 peripheral neuropathy, per common terminology criteria for adverse events (CTCAE) v5.0] from the acute toxic effects of all prior anticancer therapy before Cycle 1 Day 1
10. Must have no prior history of lenvatinib treatment

Eligibility for optional lenvatinib crossover:

1. Disease progression per RECIST 1.1 (as confirmed by IIR for all participants who crossover prior to the study data-cut)
2. No new systemic anti-cancer medication administered after the last dose of study drugs
3. Meets all safety parameters listed in the inclusion criteria and none listed in the exclusion criteria
4. Study is ongoing

Exclusion Criteria:

1. Any active infection or infectious illness unless fully recovered prior to Cycle 1 Day 1 (that is, no longer requiring systemic treatment)
2. Participants with central nervous system metastases are not eligible, unless they have completed local therapy (example, whole brain radiation therapy, surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 2 weeks before Cycle 1 Day 1
3. Active second malignancy within 2 years prior to enrollment ([in addition to osteosarcoma], but not including definitively treated superficial melanoma, carcinoma-in-situ, basal or squamous cell carcinoma of the skin)
4. Has had major surgery within 3 weeks prior to Cycle 1 Day 1. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility
5. A clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolonged QT or corrected QT (QTc) interval (example, a repeated demonstration of a QTc interval greater than [>] 480 millisecond [msec])
6. Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted
7. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib
8. Pre-existing Grade >=3 gastrointestinal or non-gastrointestinal fistula
9. Gastrointestinal bleeding or active hemoptysis (bright red blood of at least 1 divided [/] by 2 teaspoon) within 3 weeks prior to Cycle 1 Day 1
10. Radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel. Additionally, the degree of proximity to major blood vessels should be considered for exclusion because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy
11. History of ifosfamide-related Grade >=3 nephrotoxicity or encephalopathy
12. Known to be human immunodeficiency virus (HIV) positive
13. Known active Hepatitis B (example, Hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (example, hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected). Note: Testing for Hepatitis B or Hepatitis C is required at screening only when mandated by local health authority

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomization Phase: Lenvatinib + Ifosfamide + Etoposide; Participants with relapsed or refractory osteosarcoma will receive lenvatinib in combination with ifosfamide and etoposide.	Drug: Lenvatinib; Lenvatinib 14 milligrams per square meter (mg/m^2) capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or discontinuation of study by the sponsor. An extemporaneous suspension of lenvatinib capsules may be used for participants unable to swallow capsules.; Other Names: E7080; Drug: Ifosfamide; Ifosfamide 3000 milligrams per square meter per day (mg/m^2/day) intravenous infusion will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.; Drug: Etoposide; Etoposide 100 mg/m^2/day intravenous infusion will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.; Drug: Lenvatinib; Lenvatinib 14 mg/m^2 capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until the next PD (per response evaluation criteria in solid tumors [RECIST] 1.1 as assessed by investigator), development of unacceptable toxicity, participant request, or withdrawal of consent, whichever occurs first.; Other Names: E7080
Active Comparator: Randomization Phase: Ifosfamide + Etoposide; Participants with relapsed or refractory osteosarcoma will receive ifosfamide with etoposide. Participants with relapsed or refractory osteosarcoma may receive optional lenvatinib plus or minus chemotherapy (Ifosfamide and Etoposide) if disease progression is observed in study.	Drug: Lenvatinib; Lenvatinib 14 milligrams per square meter (mg/m^2) capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until disease progression (PD), development of unacceptable toxicity, participant request, withdrawal of consent, or discontinuation of study by the sponsor. An extemporaneous suspension of lenvatinib capsules may be used for participants unable to swallow capsules.; Other Names: E7080; Drug: Ifosfamide; Ifosfamide 3000 milligrams per square meter per day (mg/m^2/day) intravenous infusion will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.; Drug: Etoposide; Etoposide 100 mg/m^2/day intravenous infusion will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.; Drug: Lenvatinib; Lenvatinib 14 mg/m^2 capsules will be administered once daily on Days 1 to 21 of each 21-day cycle until the next PD (per response evaluation criteria in solid tumors [RECIST] 1.1 as assessed by investigator), development of unacceptable toxicity, participant request, or withdrawal of consent, whichever occurs first.; Other Names: E7080

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) by Independent Imaging Review (IIR) Assessment	PFS as assessed by IIR was defined as the time from the date of randomization to the date of the first documentation of PD or date of death (whichever occurred first), as determined using RECIST v1.1. PD was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was analyzed using Kaplan-Meier method.	From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first (up to 14.2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With PFS at Month 4 (PFS-4m Rate) by IIR Assessment	PFS rate at 4 months as assessed by IIR was defined as the percentage of participants who were alive and without PD at 4 months from the randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. The PFS-4m was estimated using the Kaplan-Meier method. Final analysis data was reported for this outcome measure.	Month 4
Percentage of Participants With PFS at 1 Year or Month 12 (PFS-1y Rate) by IIR Assessment	PFS-1y rate as assessed by IIR was defined as the percentage of participants who were alive and without PD at 1 year from randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS-1y rate was estimated using Kaplan-Meier method. Final analysis data was reported for this outcome measure.	Month 12 or 1 Year
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death from any cause. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2025).	From the date of randomization to the date of death from any cause (up to approximately 59 months)
Percentage of Participants With Overall Survival at 1 Year or Month 12 (OS-1y)	OS-1y was defined as the time from the date of randomization to the date of death from any cause assessed up to 1 year. OS was calculated using the Kaplan-Meier method. Final analysis data was reported for this outcome measure.	Month 12 or 1 Year
Objective Response Rate at Month 4 (ORR-4m) by IIR Assessment	ORR-4m was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined by IIR using RECIST v1.1 within the first 4 months. CR: 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 to less than (<) 10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 95% confidence interval (CI) of ORR was calculated using the method of Clopper and Pearson. Final analysis data was reported for this outcome measure.	Month 4
ORR by IIR Assessment	ORR by IIR was defined as the percentage of participants with best overall response of CR or PR determined using RECIST v1.1. CR: 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 to <10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 95% CI of ORR was calculated using the method of Clopper and Pearson. Final analysis data was reported for this outcome measure.	From the date of randomization to the date of the first documentation of CR or PR, whichever occurred first (up to approximately 14.2 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)	TEAE was defined as an adverse event (AE) that emerged during time from first dose to 30 days following last dose of drug, 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 pretreatment state, when AE was continuous. SAE was defined as untoward medical occurrence that at any dose resulted in death; was life threatening; resulted in persistent or significant disability; was congenital anomaly or medically important due to other reasons than above mentioned criteria. Data for this outcome measure will be reported after study completion (anticipated study completion date is March 2025).	From date of first dose up to 30 days after the last dose of study drug (up to approximately 60 months)
Treatment Arm A: Plasma Concentration of Lenvatinib	Plasma concentration of lenvatinib in participants from Treatment Arm A (Lenvatinib + Ifosfamide + Etoposide) at different time points were reported. As planned, data for this outcome measure was analyzed for treatment arm A only. Lenvatinib concentration in plasma was quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Final analysis data was reported for this outcome measure.	Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: Pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: Pre-dose (each Cycle length = 21 days)
Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Scale: Generic Core Scale Score at Month 4	Health-Related Quality of Life (HRQoL): PedsQL 4.0 Generic Core Scale is a multidimensional scale. It included assessment of 4 dimensions: physical functioning (8 items), emotional functioning (8 items), social functioning (8 items), and school functioning (5 items - children greater than or equal to [>=] 5 years, adults; 3 items - toddlers [aged 2-4 years]). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Generic Core Scale total score: sum of all the items divided by the number of items answered across all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL. Final analysis data was reported for this outcome measure.	Baseline and Month 4
Change From Baseline in PedsQL Scale: Cancer Module Scale Score at Month 4	HRQoL: PedsQL 3.0 Cancer Module Scale measured pediatric cancer-specific HRQoL. It included assessment of 8 dimensions: pain and hurt (2 items), nausea (5 items), procedural anxiety (3 items), treatment anxiety (3 items), worry (3 items), cognitive problems (3 items - toddlers [aged 2-4], 4 items - young children [aged 5-7]; 5 items for children aged >=8 years, adults), perceived physical appearance (3 items), communication (3 items). Each item was reported using a 5-point Likert scale, items were then reverse-scored and linearly transformed to a 0 to 100 scale. Cancer Module total score: sum of all items divided by the number of items answered on all the scales. Total score ranges from 0 to 100, where higher scores=better HRQoL, lower scores=worse HRQoL. Final analysis data was reported for this outcome measure.	Baseline and Month 4
Number of Participants Categorized Based on Overall Palatability and Acceptability Questionnaire Responses for Suspension of Lenvatinib	The palatability and acceptability of lenvatinib oral suspension formulation was assessed using the Palatability Questionnaire. In the questionnaire, participants were asked to answer palatability and acceptability of lenvatinib suspension considering the following elements: taste, appearance, smell, how does it feel in the mouth and overall acceptability in terms of 7 responses: Super good, really good, good, may be good or may be bad, bad, really bad, super bad. In this outcome measure, number of participants have been reported per their overall palatability and acceptability responses. Final analysis data was reported for this outcome measure.	Cycle 1 Day 1 (Cycle length = 21 days)

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Gaspar N, Venkatramani R, Hecker-Nolting S, Melcon SG, Locatelli F, Bautista F, Longhi A, Lervat C, Entz-Werle N, Casanova M, Aerts I, Strauss SJ, Thebaud E, Morland B, Nieto AC, Marec-Berard P, Gambart M, Rossig C, Okpara CE, He C, Dutta L, Campbell-Hewson Q. Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050): a multicentre, open-label, multicohort, phase 1/2 study. Lancet Oncol. 2021 Sep;22(9):1312-1321. doi: 10.1016/S1470-2045(21)00387-9. Epub 2021 Aug 17.
• Gaspar N, Campbell-Hewson Q, Huang J, Okpara CE, Bautista F. OLIE, ITCC-082: a Phase II trial of lenvatinib plus ifosfamide and etoposide in relapsed/refractory osteosarcoma. Future Oncol. 2021 Nov;17(32):4249-4261. doi: 10.2217/fon-2021-0743. Epub 2021 Aug 12.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): August 17, 2023

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pediatrics; Lenvatinib; Etoposide; Chemotherapy; Osteosarcoma; Ifosfamide; E7080; Relapsed or Refractory Osteosarcoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Osteosarcoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Protein Kinase Inhibitors; Etoposide; Ifosfamide; Lenvatinib
• Other Study ID Numbers: E7080-G000-230; 2019-003696-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No