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Completed Phase 1 Interventional

VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors

ClinicalTrials.gov ID: NCT02164838

Public ClinicalTrials.gov record NCT02164838. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 5:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Study of the VEGF Receptor Tyrosine Kinase Inhibitor Axitinib (INLYTA, IND# TBD) in Children With Recurrent or Refractory Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02164838
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Children's Oncology Group
Network
Enrollment
51 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Months to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2014 (Type not available)
Primary completion
Oct 19, 2017 (Actual)
Completion
Oct 19, 2017 (Actual)
Last update posted
Jan 29, 2018

2014 – 2017

United States locations

U.S. sites
20
U.S. states
18
U.S. cities
20
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 —
Childrens Hospital of Orange County Orange California 92868 —
UCSF Medical Center-Parnassus San Francisco California 94143 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Children's Healthcare of Atlanta - Egleston Atlanta Georgia 30322 —
Ann and Robert H Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Riley Hospital for Children Indianapolis Indiana 46202 —
Mark O Hatfield-Warren Grant Magnusun Clinical Center Bethesda Maryland 20892 —
C S Mott Children's Hospital Ann Arbor Michigan 48108 —
University of Minnesota Cancer Center-Fairview Minneapolis Minnesota 55455 —
Washington University School of Medicine St Louis Missouri 63110 —
Columbia University Medical Center New York New York 10032 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
Oregon Health and Science University Portland Oregon 97239 —
Childrens Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224 —
St. Jude Children's Research Hospital Memphis Tennessee 38105 —
Baylor College of Medicine Houston Texas 77030 —
Seattle Children's Hospital Seattle Washington 98145 —
Midwest Children's Cancer Center Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02164838, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 29, 2018 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02164838 live on ClinicalTrials.gov.

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