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

PHASE2CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

March 23, 2020

Primary Completion Date

June 22, 2022

Study Completion Date

August 17, 2023

Conditions
Osteosarcoma
Interventions
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."

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.

Trial Locations (84)

10065

Memorial Sloan Kettering Cancer Center, New York

20010

Children's National Medical Center, Washington D.C.

35233

Children's of Alabama, Birmingham

37232

Vanderbilt University Medical Center, Nashville

39216

University of Mississippi Medical Center, Jackson

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital For Children, Indianapolis

75235

Children's Medical Center Dallas, Dallas

76104

Cook Children's Health Care System, Fort Worth

77030

Texas Children's Hospital, Houston

80045

Childrens Hospital Colorado, Aurora

92354

Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

94143

UCSF Benioff Children's Hospitals, San Francisco

02215

Dana Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

Unknown

Chris O'Brien Lifehouse Hospital, Camperdown

Perth Childrens Hospital, Nedlands

Royal Children's Hospital Melbourne, Parkville

Queensland Children's Hospital, South Brisbane

Children's Hospital at Westmead, Westmead

St. Anna Kinderspital, Vienna

UZ Gent, Ghent

Hospital For Sick Children, Toronto

FN Brno 2 Detska Klinika, Brno

Fakultní nemocnice v Motole, Prague

Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin, Bordeaux

Centre Oscar Lambret, Lille

Centre Léon Berard, Lyon

Hopitaux de La Timone, Marseille

Hôpital de La Mère Et de L'enfant, Nantes

CHU de Nice, Nice

Hôpital Armand Trousseau, Paris

Institut Curie, Paris

Hopital de Hautepierre, Strasbourg

Hôpital Des Enfants, Toulouse

CHRU Nancy, Vandœuvre-lès-Nancy

Institut Gustave Roussy, Villejuif

Hong Kong Children's Hospital, Hong Kong

Prince of Wales Hospital, Hong Kong

Children's Health Ireland at Crumlin, Dublin

Schneider Children's Medical Center of Israel, Petah Tikva

Istituti Ortopedici Rizzoli, Bologna

Azienda Ospedaliera A Meyer, Florence

Istituto Giannina Gaslini, Genova

Istituto Nazionale Dei Tumori, Milan

IRCCS Ospedale Pediatrico Bambino Gesù, Roma

Princess Maxima Center for Pediatric Oncology, Utrecht

Auckland City Hospital, Auckland

Starship Children's Hospital, Auckland

KK Women's and Children's Hospital, Singapore

National Cancer Centre, Singapore

National University Hospital, Singapore

National Cancer Center, Goyang-si

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Severance Hospital Yonsei University Health System, Seoul

Hospital Universitario de Cruces, Barakaldo

Hospital Sant Joan de Deu, Barcelona

Hospital Universitario Vall d'Hebrón, Barcelona

Hospital Infantil Universitario Niño Jesus, Madrid

Hospital Universitario Fundacion Jimenez Diaz, Madrid

Hospital Universitario La Paz, Madrid

Hospital Universitario Virgen del Rocio, Seville

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

Drottning Silvias Barn Och Ungdomssjukhus, Gothenburg

Skanes Universitetssjukhus Lund, Lund

Karolinska Universitetssjukhuset Solna, Stockholm

Centre Hospitalier Universitaire Vaudois, Lausanne

Kinderspital Zürich - Eleonorenstiftung, Zurich

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Birmingham Children's Hospital, Birmingham

The Royal Hospital for Children, Bristol

Royal Hospital for Children, Glasgow

Leeds Children Hospital, Leeds

Alder Hey Children's Hospital, Liverpool

UCL Cancer Institute, London

Royal Manchester Childrens Hospital, Manchester

The Christie NHS Foundation Trust, Manchester

Royal Victoria Infirmary, Newcastle

John Radcliffe Hospital, Oxford

FI-33520

Tampereen yliopistollinen sairaala, Tampere

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Eisai Inc.

INDUSTRY

NCT04154189 - 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 | Biotech Hunter | Biotech Hunter