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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: Completed Phase 1 study of Refractory or Recurrent Solid Tumors, Excluding CNS Tumors, sponsored by Children's Oncology Group.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT02164838 record still lists
NCT02164838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
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 names 20 study sites across 18 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02164838's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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