A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
NCT ID: NCT04447755
Last Updated: 2025-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2020-07-30
2025-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ewing Sarcoma
Participants with Ewing sarcoma will receive lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Rhabdomyosarcoma
Participants with rhabdomyosarcoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
High Grade Glioma
Participants with high grade glioma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Diffuse Midline Glioma
Participants with diffuse midline glioma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Medulloblastoma
Participants with medulloblastoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Ependymoma
Participants with ependymoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Other Solid Tumors Excluding Osteosarcoma, Diffuse Midline Glioma, Medulloblastoma and Ependymoma
Participants with other solid tumors will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Interventions
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Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has measurable disease as defined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) for High Grade Glioma (HGG)
* Has a performance status defined as follows: 1) Lansky Play Score ≥50 for participants up to and including 16 years of age 2) Karnofsky performance status (KPS) ≥50 for participants \>16 years of age 3) Neurologic deficits in participants with primary central nervous system (CNS) tumors must have been stable for at least 7 days prior to study enrollment
* Demonstrate adequate organ function
* No clinical evidence of nephrotic syndrome.
* Has adequate blood pressure (BP) control with or without antihypertensive medications
* Has adequate cardiac function
* Has adequate neurologic function
* Participant must have fully recovered to Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0) Grade ≤1 (except for alopecia, ototoxicity, and Grade ≤2 peripheral neuropathy) from the acute toxic effects of all prior anticancer therapy
* Male participants must agree to use approved contraception during the treatment period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period
* Female participants are not pregnant and not breastfeeding, and are not a woman of childbearing potential (WOCBP) or are a WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 30 days after the last dose of study intervention
Exclusion Criteria
* Has gastrointestinal (GI) bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment
* Has CNS tumors with a history of symptomatic tumor hemorrhage
* Has evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment
* Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation
* Has evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease.
* Has GI malabsorption, GI anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib
* Has preexisting ≥Grade 3 GI or non-GI fistula
* Has any active infection requiring systemic therapy
* Known to be Human immunodeficiency virus (HIV) positive
* Known active viral hepatitis (B or C) as demonstrated by positive serology. Testing for hepatitis B or hepatitis C is required at screening only when mandated by local health authority
* Is currently participating and receiving study therapy, or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the date of allocation
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Has known hypersensitivity to any component of the investigational product (lenvatinib or ingredients)
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the stud
* 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
* Has non-healing wound, tumor ulceration, unhealed or incompletely healed fracture, or a compound (open) bone fracture at the time of enrollment
2 Years
21 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Children's Hospital of Colorado ( Site 0110)
Aurora, Colorado, United States
Cleveland Clinic ( Site 0119)
Cleveland, Ohio, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102)
Nashville, Tennessee, United States
Mary Crowley Cancer Research Center ( Site 0107)
Dallas, Texas, United States
Hospital Universitario Austral ( Site 0126)
Pilar, Buenos Aires, Argentina
Hospital de Niños Ricardo Gutiérrez ( Site 0125)
Buenos Aires, Buenos Aires F.D., Argentina
Sydney Children's Hospital ( Site 0801)
Randwick, New South Wales, Australia
Queensland Children s Hospital ( Site 0804)
Brisbane, Queensland, Australia
Royal Childrens Hospital Melbourne ( Site 0802)
Parkville, Victoria, Australia
Perth Children s Hospital ( Site 0803)
Nedlands, Western Australia, Australia
UZ Gent ( Site 0250)
Ghent, Oost-Vlaanderen, Belgium
Klinicki bolnicki centar Rijeka ( Site 0726)
Rijeka, Primorje-Gorski Kotar County, Croatia
Klinika za djecje bolesti Zagreb ( Site 0725)
Zagreb, Zagreb County, Croatia
Fakultni Nemocnice Brno Bohunice ( Site 0651)
Brno, Brno-mesto, Czechia
Fakultni nemocnice v Motole ( Site 0650)
Prague, , Czechia
Centre Leon-Berard ( Site 0326)
Lyon, Auvergne, France
Hopital La Timone ( Site 0328)
Marseille, Bouches-du-Rhone, France
Gustave Roussy ( Site 0327)
Villejuif, Val-de-Marne, France
Institut Curie ( Site 0325)
Paris, , France
Unidad Nacional de Oncologia Pediatrica ( Site 0176)
Guatemala City, , Guatemala
Medi-K Cayala ( Site 0177)
Guatemala City, , Guatemala
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0678)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Semmelweis University ( Site 0675)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0677)
Debrecen, , Hungary
Chaim Sheba Medical Center ( Site 0500)
Ramat Gan, , Israel
IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)
Rome, Roma, Italy
A.O.Universitaria Meyer-Oncology & Haematology Unit ( Site 0400)
Florence, Tuscany, Italy
Istituto Giannina Gaslini ( Site 0411)
Genova, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0401)
Milan, , Italy
Ospedale Infantile Regina Margherita ( Site 0412)
Torino, , Italy
Starship Childrens Hospital ( Site 0826)
Auckland, , New Zealand
Clinica Anglo Americana ( Site 0203)
San Isidro, Lima region, Peru
Dmitry Rogachev National Research Center ( Site 0550)
Moscow, Moscow, Russia
St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0554)
Saint Petersburg, Sankt-Peterburg, Russia
Clinical Research Center of specialized types medical care-Oncology ( Site 0553)
Saint Petersburg, Sankt-Peterburg, Russia
Institute for Oncology and Radiology of Serbia ( Site 0780)
Belgrade, Beograd, Serbia
Univerzitetska decja klinika ( Site 0782)
Belgrade, Beograd, Serbia
Wits Clinical Research ( Site 0579)
Soweto, Gauteng, South Africa
Cancercare Rondebosch Oncology ( Site 0575)
Cape Town, Western Cape, South Africa
Tygerberg Hospital ( Site 0578)
Parow, Western Cape, South Africa
Asan Medical Center ( Site 0876)
Songpagu, Seoul, South Korea
Seoul National University Hospital ( Site 0875)
Seoul, , South Korea
Hospital Universitario Sant Joan de Deu ( Site 0476)
Esplugues de Llobregat, Barcelona, Spain
Hospital Nino Jesus ( Site 0477)
Madrid, , Spain
Skanes Universitetssjukhus Lund. ( Site 0525)
Lund, Skåne County, Sweden
Hacettepe Universitesi Tip Fakultesi ( Site 0603)
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi ( Site 0601)
Izmir, , Turkey (Türkiye)
Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0602)
Izmir, , Turkey (Türkiye)
Countries
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References
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Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, Venkatramani R, Hecker-Nolting S, Gambart M, Bautista F, Thebaud E, Aerts I, Morland B, Rossig C, Canete Nieto A, Longhi A, Lervat C, Entz-Werle N, Strauss SJ, Marec-Berard P, Okpara CE, He C, Dutta L, Casanova M. 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)☆. ESMO Open. 2021 Oct;6(5):100250. doi: 10.1016/j.esmoop.2021.100250. Epub 2021 Sep 22.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7902-013
Identifier Type: OTHER
Identifier Source: secondary_id
HopSkip-013
Identifier Type: OTHER
Identifier Source: secondary_id
2024-512135-80-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1304-6856
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-004441-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7902-013
Identifier Type: -
Identifier Source: org_study_id
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