A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00560144

Run by

Hoffmann-La Roche

People needed

34

Starts

2007-12-01

Expected to finish

2011-12-01

Last updated by the study team

2016-11-01

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Denver, Colorado, United States
• Study site — Bethesda, Maryland, United States
• Study site — New York, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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