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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04447755




Registration number
NCT04447755
Ethics application status
Date submitted
23/06/2020
Date registered
25/06/2020

Titles & IDs
Public title
A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
Scientific title
An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies
Secondary ID [1] 0 0
MK-7902-013
Secondary ID [2] 0 0
7902-013
Universal Trial Number (UTN)
Trial acronym
E7080-G000-231
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenvatinib

Experimental: Ewing Sarcoma - Participants with Ewing sarcoma will receive lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.

Experimental: Rhabdomyosarcoma - Participants with rhabdomyosarcoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Experimental: High Grade Glioma - Participants with high grade glioma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Experimental: Diffuse Midline Glioma - Participants with diffuse midline glioma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Experimental: Medulloblastoma - Participants with medulloblastoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Experimental: Ependymoma - Participants with ependymoma will receive lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Experimental: 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.


Treatment: Drugs: Lenvatinib
Lenvatinib capsules administered orally at 14 mg/m\^2 QD
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) At Week 16 Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for High Grade Glioma [HGG] Only), by Investigator Assessment
Timepoint [1] 0 0
Up to 16 weeks
Secondary outcome [1] 0 0
ORR Per RECIST 1.1 or RANO Criteria (for HGG Only), by Investigator Assessment
Timepoint [1] 0 0
Up to approximately 21 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Timepoint [2] 0 0
Up to approximately 21 months
Secondary outcome [3] 0 0
Best Overall Response (BOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Timepoint [3] 0 0
Up to approximately 21 months
Secondary outcome [4] 0 0
Duration of Response (DOR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Timepoint [4] 0 0
Up to approximately 21 months
Secondary outcome [5] 0 0
Disease Control Rate (DCR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Timepoint [5] 0 0
Up to approximately 21 months
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR) Per RECIST 1.1 or RANO (for HGG Only), by Investigator Assessment
Timepoint [6] 0 0
Up to approximately 21 months
Secondary outcome [7] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [7] 0 0
Up to approximately 21 months
Secondary outcome [8] 0 0
Number of Participants Who Discontinued Study Treatment Due to an AE
Timepoint [8] 0 0
Up to approximately 20 months
Secondary outcome [9] 0 0
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Taste Category
Timepoint [9] 0 0
Cycle 1 Day 1 (cycle = 28 days)
Secondary outcome [10] 0 0
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Appearance Category
Timepoint [10] 0 0
Cycle 1 Day 1 (cycle = 28 days)
Secondary outcome [11] 0 0
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Smell Category
Timepoint [11] 0 0
Cycle 1 Day 1 (cycle = 28 days)
Secondary outcome [12] 0 0
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Mouth Feel Category
Timepoint [12] 0 0
Cycle 1 Day 1 (cycle = 28 days)
Secondary outcome [13] 0 0
Palatability Questionnaire For Lenvatinib Suspension Formulation: Participant Responses by Overall Acceptability Category
Timepoint [13] 0 0
Cycle 1 Day 1 (cycle = 28 days)
Secondary outcome [14] 0 0
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)
Timepoint [14] 0 0
Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.

Eligibility
Key inclusion criteria
* Has histologically or cytologically documented relapsed, or refractory pediatric solid malignancy excluding osteosarcoma
* 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
Minimum age
2 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has had major surgery within 3 weeks prior to Cycle 1 Day 1 (C1D1)
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/02/2025
Actual
Sample size
Target
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital ( Site 0801) - Randwick
Recruitment hospital [2] 0 0
Queensland Children s Hospital ( Site 0804) - Brisbane
Recruitment hospital [3] 0 0
Royal Childrens Hospital Melbourne ( Site 0802) - Parkville
Recruitment hospital [4] 0 0
Perth Children s Hospital ( Site 0803) - Nedlands
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Caba
Country [7] 0 0
Belgium
State/province [7] 0 0
Oost-Vlaanderen
Country [8] 0 0
Croatia
State/province [8] 0 0
Primorsko-goranska Zupanija
Country [9] 0 0
Croatia
State/province [9] 0 0
Zagrebacka Zupanija
Country [10] 0 0
Czechia
State/province [10] 0 0
Brno-mesto
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 5
Country [12] 0 0
France
State/province [12] 0 0
Auvergne
Country [13] 0 0
France
State/province [13] 0 0
Bouches-du-Rhone
Country [14] 0 0
France
State/province [14] 0 0
Val-de-Marne
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
Guatemala
State/province [16] 0 0
Guatemala
Country [17] 0 0
Hungary
State/province [17] 0 0
Borsod-Abauj-Zemplen
Country [18] 0 0
Hungary
State/province [18] 0 0
Budapest
Country [19] 0 0
Hungary
State/province [19] 0 0
Debrecen
Country [20] 0 0
Israel
State/province [20] 0 0
Ramat-Gan
Country [21] 0 0
Italy
State/province [21] 0 0
Roma
Country [22] 0 0
Italy
State/province [22] 0 0
Toscana
Country [23] 0 0
Italy
State/province [23] 0 0
Genova
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Torino
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul
Country [27] 0 0
New Zealand
State/province [27] 0 0
Auckland
Country [28] 0 0
Peru
State/province [28] 0 0
Lima
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moskva
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Sankt-Peterburg
Country [31] 0 0
Serbia
State/province [31] 0 0
Beograd
Country [32] 0 0
South Africa
State/province [32] 0 0
Gauteng
Country [33] 0 0
South Africa
State/province [33] 0 0
Western Cape
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Sweden
State/province [36] 0 0
Skane Lan
Country [37] 0 0
Turkey
State/province [37] 0 0
Ankara
Country [38] 0 0
Turkey
State/province [38] 0 0
Istanbul
Country [39] 0 0
Turkey
State/province [39] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04447755