VEGF Receptor Tyrosine Kinase Inhibitor Axitinib in Children With Recurrent or Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02164838|
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Refractory or Recurrent Solid Tumors, Excluding CNS Tumors||Drug: Axitinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||October 19, 2017|
|Actual Study Completion Date :||October 19, 2017|
Other Name: AG-013736, INLYTA®
- Adverse events as assessed by (CTCAE) version 4.0 [ Time Frame: 28 days ]
- MTD of axitinib based on dose-limiting toxicity (DLT) at which fewer than one-third of patients experience DLT, as assessed by CTCAE version 4.0 [ Time Frame: 28 days ]
- Pharmacokinetic Assessment of Axitinib Concentrations in Plasma Samples [ Time Frame: Day 1 and Day 8 of Cycle 1 ]
A descriptive analysis of pharmacokinetic (PK) parameters of axitinib will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters.
Blood samples will be collected at the following time points:Day 1, Cycle 1: Pre-dose, and at 1, 2, 4, 6, and 8 hours after the AM dose on Day 1. Day 8, Cycle 1: Pre-dose, and at 1, 2, 4, 6, and 8 hours after the AM dose on Day 8.
- Evaluation of disease response to preliminarily define the antitumor activity of axitinib [ Time Frame: up to 2 years ]Patients will have tumor disease evaluations performed at the end of cycles 1, 3, and 5 and then every 3 cycles. Disease response will be assessed according to RECIST criteria for patients with solid tumors and will be reported descriptively. Analyses will be descriptive and exploratory and hypotheses generating in nature.
- Biomarkers of kidney injury during axitinib treatment [ Time Frame: Cycles 1 and 3 ]Proteins in the blood (cystatin C and neutrophil gelatinase-associated lipocalcin (NGAL)) and urine (kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), creatinine and other markers of renal injury) will be measured before treatment and then weekly during Cycle 1 of axitinib treatment and at the end of Cycle 3
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164838
|Principal Investigator:||James Geller, MD||Children's Oncology Group|