Spots Global Cancer Trial Database for A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
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Trial Identification
Brief Title: A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
Official Title: Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.
Study ID: NCT00560144
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 2 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
, Tucson, Arizona, United States
, Denver, Colorado, United States
, Bethesda, Maryland, United States
, New York, New York, United States
, Philadelphia, Pennsylvania, United States
, Houston, Texas, United States
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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