A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- pediatric patients aged 2-17 years of age;
- histologically confirmed solid tumors;
- cancer which has relapsed after, or failed to respond to, curative therapy, or no other potentially curative treatment options available.
Exclusion criteria
- treatment with corticosteroids within past 2 weeks;
- current or past use of anti-IGF-1R antibodies;
- current treatment with immunosuppressive agents;
- patients with diabetes mellitus;
- known HIV or hepatitis B or C;
- hypersensitivity to any of the components of R1507 or to monoclonal antibodies.
Trial design
Primary purpose
Allocation
Interventional model
Masking
34 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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