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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT00560144 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00560144 record still lists
NCT00560144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which RG1507 is the first listed.
NCT00560144 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00560144's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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