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NCT00560144 · ClinicalTrials.gov registry record · Phase 1
A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT00560144 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 34 participants.
The verdict
NCT00560144, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study 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.
Interventions
- DRUG RG1507
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2007-12 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00560144
The ClinicalTrials.gov registry entry for NCT00560144 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RG1507 is the first listed.
NCT00560144 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00560144 about?
NCT00560144 is a clinical study titled "A Multiple Ascending Dose Study of R1507 in Children and Adolescents 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) an...
What is the current status of trial NCT00560144?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2007-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00560144?
The interventions under investigation include: RG1507 (DRUG).
Who is sponsoring clinical trial NCT00560144?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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