Inclusion
- ≥2 years and ≤21 years of age
- Recurrent or refractory solid tumors (excluding hepatoblastoma and lymphomas), including primary CNS tumors
- VEGF/VEGFR-targeted or mTOR-targeted therapies:
– Must not have received prior exposure to lenvatinib
– May have previously progressed on an mTOR inhibitor - No more than 2 prior VEGF/VEGFR-targeted therapies (For Phase 2 only)
- Standard COG Phase 1 organ function requirements
Exclusion
- Pulmonary dysfunction
- Major surgery within 28 days
- Non-healing wound, unhealed or incompletely healed fracture
- Nephrotic syndrome
- Gastrointestinal bleeding or active hemoptysis
- Thrombotic/ thromboembolic event requiring systemic anticoagulation within 90 days
- New intracranial hemorrhage of more than punctate size on MRI assessment (HGG)
- Diagnosis of lymphoma
- Major blood vessel invasion/infiltration.
- Untreated CNS metastases
- Excluded concomitant medications: Corticosteroids (unless on stable dosing), other investigational drugs, other anti-cancer agents, anti-GvHD agents post-transplant, strong CYP1A2 inhibitors w/I past 7 days prior to enrollment, or enzyme-inducing anticonvulsants, and anticoagulants
