Trials / Completed
CompletedNCT02164838
VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors
A Phase 1 Study of the VEGF Receptor Tyrosine Kinase Inhibitor Axitinib (INLYTA, IND# TBD) in Children With Recurrent or Refractory Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- 12 Months – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Axitinib |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2017-10-19
- Completion
- 2017-10-19
- First posted
- 2014-06-17
- Last updated
- 2018-01-29
Locations
21 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02164838. Inclusion in this directory is not an endorsement.