Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.
Phase 1
2 Years
17 Years
2 Years
17 Years
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NO21200
NCT ID:
NCT00560144
Start Date:
December 2007
Completion Date:
December 2011
Related Keywords:
- Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Phoenix, Arizona 85012 | |
| Albany, New York 12208 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 |
