A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | December 2007 |
| End Date: | December 2011 |
Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.
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.
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.
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.
We found this trial at
6
sites
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