Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies an… (NCT02432274) | Clinical Trial Compass
CompletedPhase 1/2
Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma
United States, France117 participantsStarted 2014-12-29
Plain-language 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).
Who can participate
Age range2 Years – 25 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed diagnosis of solid malignant tumor.
✓. Cohort 1: Any solid malignant tumor.
✓. Cohort 2A: Differentiated Thyroid Cancer (DTC) with one of the following histological subtypes:
✓. Relapsed or refractory solid tumor malignancy that has progressed on standard anticancer therapy with no available curative options. (Note: Osteosarcoma participants must be in first or subsequent relapse \[greater than or equal to first relapse\]). Only the osteosarcoma participants enrolled to Cohorts 3A and 3B must be deemed candidates for ifosfamide and etoposide chemotherapy).
✓. Evaluable or measurable disease that meets the following criteria:
✓. Participants must have evaluable or measurable disease based on RECIST 1.1 using computed tomography (CT)/magnetic resonance imaging (MRI).
✓. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have subsequently grown unequivocally to be deemed a target lesion.
✓. DTC participants must be 131 iodine-refractory/ relapsed as defined by at least one of the following:
Exclusion criteria
✕. Any active infection or infectious illness unless fully recovered prior to dosing.
✕. Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.
What they're measuring
1
Cohort 1: Recommended Dose (RD) of Lenvatinib
Timeframe: Cycle 1 (28 days)
2
Cohort 2A: Number of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
Timeframe: From date of first dose of study drug until first documentation of PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)
3
Cohort 2A: Number of Participants With Best Overall Response (BOR)
Timeframe: From first dose of study drug until PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)
4
Cohorts 2B and 3B: Progression-free Survival (PFS) Rate at Month 4
Timeframe: At Month 4
5
Cohort 3A: Recommended Dose (RD) of Lenvatinib When Given in Combination With Etoposide and Ifosfamide
✕. Other organ toxicity due to prior anticancer therapy (investigational agent, chemotherapy, or radiation therapy) except alopecia, and ototoxicity due to cisplatin not already covered in the inclusion/exclusion criteria, which has not recovered to Grade less than 2 per Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
✕. Known hypersensitivity to any component of the product (lenvatinib or ingredients).
✕. Concurrent administration of any other antitumor therapy.
✕. Previous treatment with lenvatinib (except for participants previously enrolled into Cohorts 1 or 2B of this study).
✕. Two or more prior vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted therapies.
✕. Currently receiving any investigational drug or device in another clinical trial or within 30 days preceding informed consent.