Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.
- 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.
- 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.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
Outcome Time Frame:
United States: Food and Drug Administration
||Phoenix, Arizona 85012
||Albany, New York 12208
||Philadelphia, Pennsylvania 19104
||Austin, Texas 78705
||Baltimore, Maryland 21287