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NCT02164838 · ClinicalTrials.gov registry record · Phase 1
VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors
A Phase 1 study of Refractory or Recurrent Solid Tumors, Excluding CNS Tumors, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 20
- Study locations
NCT02164838 is a Phase 1 study of Refractory or Recurrent Solid Tumors, Excluding CNS Tumors that has completed, run by Children's Oncology Group. The registered enrollment target is 51 participants. The trial reports 20 study locations across 18 states.
The verdict
NCT02164838, a Phase 1 study of Refractory or Recurrent Solid Tumors, Excluding CNS Tumors, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Axitinib
Study Locations (20)
California
- Childrens Hospital of Orange County - Orange
- UCSF Medical Center-Parnassus - San Francisco
Pennsylvania
- Childrens Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Alabama
- Children's Hospital of Alabama - Birmingham
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Egleston - Atlanta
Illinois
- Ann and Robert H Lurie Children's Hospital of Chicago - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Maryland
- Mark O Hatfield-Warren Grant Magnusun Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-09 |
| Est. Completion | 2017-10-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02164838
The ClinicalTrials.gov registry entry for NCT02164838 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Refractory or Recurrent Solid Tumors, Excluding CNS Tumors appearing as the primary indexed condition, and to 1 intervention - of which Axitinib is the first listed.
NCT02164838 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, Pennsylvania, Alabama.
Frequently Asked Questions
What is clinical trial NCT02164838 about?
NCT02164838 is a clinical study titled "VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors". 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 meas...
What is the current status of trial NCT02164838?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2014-09. Estimated completion is 2017-10-19.
What conditions does trial NCT02164838 study?
This clinical trial studies the following conditions: Refractory or Recurrent Solid Tumors, Excluding CNS Tumors.
What interventions are being tested in trial NCT02164838?
The interventions under investigation include: Axitinib (DRUG).
Who is sponsoring clinical trial NCT02164838?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02164838 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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