This phase I/II trial is studying the side effects and best dose of sorafenib in treating young patients with relapsed or refractory solid tumors or leukemia. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
Age range
2 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Patients With Treatment-related Dose Limiting Toxicity in Cycle 1 by Dose Level
Timeframe: Up to 28 days
Number of Patients With Treatment-related Adverse Events
Timeframe: Up to 2 years
Area Under the Plasma Concentration Versus Time Curve (AUC) of Sorafenib
Timeframe: During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
Clearance (Cl) of Sorafenib
Timeframe: During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
Half-life of Sorafenib
Timeframe: During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
Maximum Serum Concentration (Cmax) of Sorafenib
Timeframe: During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
Number of Patients With Treatment-related Dose Limiting Toxicities in Later Cycles by Dose Level
Timeframe: Up to 2 years
Area Under the Plasma Concentration Versus Time Curve (AUC) of Sorafenib
Timeframe: 8 hours post dose on day 1 of cycle 1
Clearance (Cl) of Sorafenib
Timeframe: 8 hours post dose on day 1 of cycle 1
Half-life of Sorafenib
Timeframe: 8 hours post dose on day 1 of cycle 1
Volume of Distribution at Steady State (Vss) of Sorafenib
Timeframe: 8 hours post dose on day 1 of cycle 1
Maximum Serum Concentration (Cmax) of Sorafenib
Timeframe: 8 hours post dose on day 1 of cycle 1