ADVL1711: A Phase 1/2 Study of Lenvatinib in Combination with Everolimus in Recurrent and Refractory Pediatric Solid Tumors, including CNS Tumors

About this Study

In this study, the drugs lenvatinib and everolimus are being given in combination. The main purpose of this study is to study the effects of this combination of study drugs on the body; to assess the activity of study drugs in combination; to assess any shrinkage in tumor size; to determine what happens to the study drugs in the body (how they are absorbed, distributed, broken down, and excreted); to assess biomarkers (markers that may help researchers understand the disease and effectiveness of lenvatinib and everolimus) in blood and tumor tissues.

Sponsor Protocol ID:E7080-A001-216
IRB Number:2019-0228
Actively Enrolling
Phase 1
November 14, 2019
Eligibility Criteria
2 years old
18 years old
Both Male and Female

Inclusion CriteriaMale or female subjects must be ≥2 years and

Exclusion Criteria1. Subjects who have had or are planning to have the following invasive procedures: 
 Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment. 
 Central line placement or subcutaneous port placement is not considered major surgery. External central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment. 
 Fine needle aspirate within 7 days prior to enrollment. 
 Surgical or other wounds must be adequately healed prior to enrollment.

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Participating Locations
Batson Children’s Hospital
Contact Information
Contact Name: Maggie Goad
Phone Number: 601-984-2700
Principal Investigator:Collier, Anderson B, M.D.
How to participate in our Clinical Trials