Expired Study
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New York, New York 10017


Purpose:

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.


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.


NCT ID:

NCT00560144


Primary Contact:

Study Director
Clinical Trials
Hoffmann-La Roche


Backup Contact:

N/A


Location Contact:

New York, New York 10017
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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