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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512135-80-00
Acronym
MK-7902-013
Enrollment
57
Registered
2024-06-18
Start date
2020-07-13
Completion date
2025-02-05
Last updated
2024-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Between ages 2 and 21 and have High Grade Glioma (HGG), Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (pPNET), or other solid tumor types (except osteosarcoma), Rhabdomyosarcoma (RMS)

Brief summary

1. 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

Detailed description

1. ORR per RECIST 1.1 or RANO Criteria (for HGG only), by Investigator Assessment, 2. Progression Free Survival (PFS) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 3. Best Overall Response (BOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 4. Duration of Response (DOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 5. Disease Control Rate (DCR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 6. Clinical Benefit Rate (CBR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 7. Number of Participants who Experience an Adverse Event (AE), 8. Number of Participants who Discontinue Study Treatment Due to an AE, 9. Palatability Questionnaire Score For Lenvatinib Suspension Formulation, 10. Area Under the Concentration-Time Curve of lenvatinib From Time 0 to Infinity (AUC 0-inf)

Interventions

DRUGLenvatinib

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
1. 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

Secondary

MeasureTime frame
1. ORR per RECIST 1.1 or RANO Criteria (for HGG only), by Investigator Assessment, 2. Progression Free Survival (PFS) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 3. Best Overall Response (BOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 4. Duration of Response (DOR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 5. Disease Control Rate (DCR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 6. Clinical Benefit Rate (CBR) per RECIST 1.1 or RANO (for HGG only), by Investigator Assessment, 7. Number of Participants who Experience an Adverse Event (AE), 8. Number of Participants who Discontinue Study Treatment Due to an AE, 9. Palatability Questionnaire Score For Lenvatinib Suspension Formulation, 10. Area Under the Concentration-Time Curve of lenvatinib From Time 0 to Infinity (AUC 0-inf)

Countries

Czechia, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026