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: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal

Criteria

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.