None listed
Conditions
Interventions
Lenvatinib Type of group
Lenvatinib oral 14mg/m2 once daily for 39 months
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Has histologically or cytologically documented relapsed, or refractory pediatric solid malignancy excluding osteosarcoma. 2. Has measurable disease as defined by RECIST 1.1 or RANO for HGG, meeting the criteria listed in the Protocol. 3. Has a performance status as defined in the Protocol. 4. Demonstrate adequate organ function as defined in the Protocol. 5. Urine dipstick <2+ for proteinuria. 6. No clinical evidence of nephrotic syndrome. 7. Has adequate BP control with or without antihypertensive medications. 8. Has adequate cardiac function. 9. Has adequate neurologic function. 10. Participant must have fully recovered to CTCAE v5.0 Grade ≤1 (except for alopecia, ototoxicity, and Grade ≤2 peripheral neuropathy) from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer-directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, eg, blood count criteria, the participant is considered to have recovered adequately. 11. Male or female ≥2 years to ≤ 18 years of age (≤21 years for EWS/pPNET), on the day the main informed consent/assent is signed. 12. Male participants are eligible to participate if they agree to following contraceptives methods describe in the Protocol during the intervention period and for at least 30 days after the last dose of study intervention. 13. A female participant is eligible to participate if she is not pregnant or breastfeeding, and meet at least one of the conditions described in the Protocol. 14. Be willing and able to provide (and/or their parents or legal guardians) written informed consent/assent for the study. Written informed consent required from participants ≥18 years. 15. Willing and able to comply with the protocol, scheduled follow-up, and management of toxicity as judged by the investigator. Please refer to the protocol for more information.
Exclusion criteria
Exclusion criteria: 1. Is a WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study intervention 2. Has had major surgery within 3 weeks prior to C1D1. 3. Has GI bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 21 days prior to enrollment. 4. Has CNS tumors with a history of symptomatic tumor hemorrhage. 5. Has evidence of new intracranial hemorrhage of more than punctate size on MRI assessment obtained within 28 days prior to study enrollment. 6. Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation 7. Has evidence of untreated CNS metastases (exception: participants with primary CNS tumors and leptomeningeal disease) 8. Has GI malabsorption, GI anastomosis, or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib. 9. Has preexisting ≥Grade 3 GI or non-GI fistula. 10. Has any active infection requiring systemic therapy. 11. A clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval >480 msec) 12. Known to be HIV positive. Note: HIV testing is required at screening only when mandated by local health authority. 13. Active viral hepatitis (B or C) as demonstrated by positive serology. 14. 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 15. 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 16. Has known hypersensitivity to any component of the investigational product (lenvatinib or ingredients) 17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. Please refer to the protocol for more information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Method of Clopper and Pearson. Measure:To determine the Objective Response Rate (ORR) by each tumor type, per RECIST 1.1 or RANO (for HGG only) as assessed by the investigator. Timepoints:The primary analysis will be conducted on week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Method of Clopper and Pearson. Measure:To evaluate ORR, by each tumor type, per RECIST 1.1 or RANO (for HGG only) as assessed by the investigator. Timepoints:Objective Response, defined as a confirmed (≥4 weeks after initial response) CR or PR. ; Outcome name:Kaplan-Meier product-limit estimates. Measure:To evaluate PFS per RECIST 1.1 or RANO (for HGG only), by each tumor type. Timepoints:PFS defined as the time from the date of the first administration of lenvatinib until the date of first documentation of PD or death (whichever occurs first) ; Outcome name:Method of Clopper and Pearson / Kaplan-Meier approach. Measure:To evaluate the BOR, DOR, DCR, and CBR, by each tumor type. Timepoints:• BOR defined as the participant’s best confirmed response (CR or PR) over the treatment period. • DOR defined as the time from the date of the first documented CR or PR to the date first documentation of progressive disease or death(whichever occurs first). • Disease control defined as a BOR of CR or PR, or SD. | — |
Countries
Argentina, Australia, Belgium, Croatia, Czech Republic, France, Guatemala, Hungary, Israel, Italy, Korea South, New Zealand, Russian Federation, South Africa, Spain, Sweden, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed