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)
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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