Trial information
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
Status: Recruiting
Protocol number: NO21200
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Multiple Ascending Dose (MAD) study of the IGF-1R Antagonist R1507 administered as an intravenous infusion in pediatric patients with advanced solid tumors.
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. Target sample size is 39.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Neoplasms
Intervention type: Drug
Intervention name: R1507
Primary outcome: 1. Serum drug exposure level equivalent to exposure in adults at adult recommended dose. Time frame: Throughout study
Key secondary outcomes: 1. MTD (AEs, laboratory parameters) Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 2 Years Max: 17 Years
Accepts healthy volunteers: No
Anticipated start date: November, 2007
Trial registration date: 11/16/2007
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Tucson , AZ
- Denver, CO
- Bethesda, MD
- New York, NY
- Houston, TX
