a study on Solid Tumor
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.
A Phase 1 Study of the VEGF Receptor Tyrosine Kinase Inhibitor Axitinib (INLYTA, IND# TBD) in Children With Recurrent or Refractory Solid Tumors
Refractory or Recurrent Solid Tumors, Excluding CNS Tumors Axitinib
Open to people ages 12 months to 17 years
Adequate Renal Function Defined As:
• Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 or
Adequate Liver Function Defined as:
Adequate Cardiac Function Defined As:
Adequate Blood Pressure Control Defined As:
A blood pressure (BP) ≤ the 95th percentile for age, height, and gender
Adequate Coagulation Defined As:
Adequate Pancreatic Function Defined as:
• Lipase ≤ 1.5 x upper limit of normal (ULN).
Anti-GVHD agents post-transplant:
Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial.
Patients chronically receiving drugs that are known potent CYP3A4/5 inhibitors within 7 days prior to study enrollment, including but not limited to ketoconazole, itraconazole,clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir,telithromycin, voriconazole, grapefruit, and grapefruit juice are not eligible
Patients chronically receiving drugs that are known potent CYP3A4/5 inducers within 7 days prior to study enrollment, including but not limited to rifampin, dexamethasone,phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St John's wort are not eligible.
Bleeding and Thrombosis:
Patients with evidence of active bleeding, intratumoral hemorrhage, or bleeding diathesis are not eligible:
Surgery: Patients who have had or are planning to have the following invasive procedures are not eligible:
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