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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 16, 2007 | ||||
| Last Updated Date | November 17, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Serum drug exposure level equivalent to exposure in adults at adult recommended dose. [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Pharmacokinetics: Serum drug exposure level (AUC)equivalent to exposure in adults at adult recommended dose. Safety: Maximum tolerated dose (AEs, lab tests). | ||||
| Change History | Complete list of historical versions of study NCT00560144 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
MTD (AEs, laboratory parameters) [ Time Frame: Throughout study ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Efficacy: Tumor response | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors. | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study | ||||
| Condition ICMJE | Neoplasms | ||||
| Intervention ICMJE | Drug: R1507 | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 39 | ||||
| Estimated Completion Date | October 2011 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 2 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00560144 | ||||
| Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
| Study ID Numbers ICMJE | NO21200 | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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