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

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

Solid Tumors

Ongoing, but not recruiting

1

Start Date 11/16/2007

Age of Trial (yrs) 17

Gleevec-resistant

IGF1R inhibitor

Block related tumor signal paths

GIST not specified. GIST patient enrollment unknown.

NO21200

Hoffman-La Roche

Hoffmann-La Roche Please reference Study ID Number: NO21200 973-235-5000 800-526-6367 (US only)

Intravenous

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.
Trials of IGF1R inhibitors such as R1507, would be most appropriate for patients with wild-type GIST and/or pediatric GIST.