CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Lenvatinib +8 moredrug
Likely dose
Lenvatinib 11 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02432274
NCT02432274Phase 2Completed
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Phase 1/2 Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma

Eisai Limited·interventional·Posted May 4, 2015·Updated Jul 11, 2023

In Brief

A Phase 2 clinical trial evaluating Lenvatinib, Ifosfamide, and 1 other intervention for Tumors and 3 related conditions. Completed, enrolled 117 participants across 19 sites in 6 countries.

Detailed Summary

This is a phase 1/2 study evaluating safety, tolerability, and efficacy of lenvatinib as single-agent, and in combination with chemotherapy (ifosfamide and etoposide) in children and adolescents with refractory or relapsed solid malignancies including differentiated thyroid carcinoma (single agent lenvatinib) and osteosarcoma (single agent and combination lenvatinib).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTumors, Solid Malignant Tumors, Osteosarcoma, Differentiated Thyroid Cancer (DTC)
CountriesFrance, Germany, Italy, Spain, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 4, 2015
Enrollment StartDec 29, 2014
Primary CompletionJul 18, 2019
Study CompletionJul 20, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 11.2 years ago

Interventions

Lenvatinibdrug

Cohort 1: Lenvatinib will be administered orally, once daily on Days 1 to 28 of each 28-day cycle at a starting dose of 11 mg/m2. Dose can be de-escalated to 9 mg/m2 or escalated to 14 and 17 mg/m2.

Lenvatinibdrug

Cohort 2A: Lenvatinib (RD determined in Cohort 1) will be administered orally, once daily on Days 1 to 28 of each 28-day cycle.

Lenvatinibdrug

Cohort 2B: Lenvatinib (RD determined in Cohort 1) will be administered orally, once daily on Days 1 to 28 of each 28-day cycle.

Lenvatinibdrug

Cohort 3A: Lenvatinib will be administered orally, once daily on Days 1 to 21 of each 21-day cycle at 20% lower than RD determined in Cohort 1 (starting dose). Lenvatinib dose can be escalated to the RD from Cohort 1 or de-escalated to 40 and 60% lower than the RD from Cohort 1.

Lenvatinibdrug

Cohort 3B: Lenvatinib will be administered orally, once daily on Days 1 to 21 of each 21-day cycle at the RD as determined in Cohort 3A.

Ifosfamidedrug

Ifosfamide 3000 mg/m2/day (starting dose) will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles. Ifosfamide dose can be de-escalated to 2400 mg/m2/day and 1800 mg/m2/day.

Etoposidedrug

Etoposide 100 mg/m2/day (starting dose) will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles. Etoposide dose can be de-escalated to 80 mg/m2/day and 60 mg/m2/day.

Ifosfamidedrug

Ifosfamide dose identified in Cohort 3A will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.

Etoposidedrug

Etoposide dose identified in Cohort 3A will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.