A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in
children and adolescents with advanced solid tumors equivalent to the exposure achieved in
adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated
dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be
sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to
exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of
patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is
until disease progression or dose limiting toxicity, and the target sample size is <100
individuals.