VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors
- Conditions
- Refractory or Recurrent Solid Tumors, Excluding CNS Tumors
- Interventions
- Registration Number
- NCT02164838
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
This trial will be the first study of axitinib in children and adolescents. The primary objective of this Phase 1 trial is to determine a maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of axitinib in pediatric patients with refractory solid tumors. Additional objectives include measurement of pharmacokinetic and pharmacodynamic parameters, description of the toxicity profile of this agent in children and adolescents, and assessment of response within the confines of a Phase 1 trial. A standard rolling 6 design will be used for dose escalation. Further development of axitinib will focus on development of a joint cooperative group (COG/ECOG) Phase 2 study of axitinib in pediatric, adolescent and young adult translocation renal cell carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Axitinib Axitinib -
- Primary Outcome Measures
Name Time Method MTD of axitinib based on dose-limiting toxicity (DLT) at which fewer than one-third of patients experience DLT, as assessed by CTCAE version 4.0 28 days Pharmacokinetic Assessment of Axitinib Concentrations in Plasma Samples Day 1 and Day 8 of Cycle 1 A descriptive analysis of pharmacokinetic (PK) parameters of axitinib will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters.
Blood samples will be collected at the following time points:Day 1, Cycle 1: Pre-dose, and at 1, 2, 4, 6, and 8 hours after the AM dose on Day 1. Day 8, Cycle 1: Pre-dose, and at 1, 2, 4, 6, and 8 hours after the AM dose on Day 8.Adverse events as assessed by (CTCAE) version 4.0 28 days
- Secondary Outcome Measures
Name Time Method Evaluation of disease response to preliminarily define the antitumor activity of axitinib up to 2 years Patients will have tumor disease evaluations performed at the end of cycles 1, 3, and 5 and then every 3 cycles. Disease response will be assessed according to RECIST criteria for patients with solid tumors and will be reported descriptively. Analyses will be descriptive and exploratory and hypotheses generating in nature.
Biomarkers of kidney injury during axitinib treatment Cycles 1 and 3 Proteins in the blood (cystatin C and neutrophil gelatinase-associated lipocalcin (NGAL)) and urine (kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), creatinine and other markers of renal injury) will be measured before treatment and then weekly during Cycle 1 of axitinib treatment and at the end of Cycle 3
Trial Locations
- Locations (21)
Childrens Hospital of Orange County
🇺🇸Orange, California, United States
Children's Healthcare of Atlanta - Egleston
🇺🇸Atlanta, Georgia, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
UCSF Medical Center-Parnassus
🇺🇸San Francisco, California, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Childrens Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Ann and Robert H Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Mark O Hatfield-Warren Grant Magnusun Clinical Center
🇺🇸Bethesda, Maryland, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
University of Minnesota Cancer Center-Fairview
🇺🇸Minneapolis, Minnesota, United States
C S Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States