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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG1507 | Drug | 3mg/kg iv weekly |
| |
| RG1507 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum drug exposure level equivalent to exposure in adults at adult recommended dose. | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| MTD (AEs, laboratory parameters) | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | 85724 | United States | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C558734 | RG-1507 monoclonal antibody |
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| Drug |
9mg/kg iv weekly |
|
| RG1507 | Drug | Pharmacokinetic-derived dose, <=16mg/kg iv weekly |
|
| Denver |
| Colorado |
| 80218 |
| United States |
| Bethesda | Maryland | 20982 | United States |
| New York | New York | 10017 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Houston | Texas | 77030 | United States |