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NCT00400296 · ClinicalTrials.gov registry record · Phase 1
A Study of R547 in Patients With Advanced Solid Tumors.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT00400296 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 58 participants.
The verdict
NCT00400296, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, on days 1 and 8 of a 21 day cycle. In the absence of dose-limiting toxicity following the starting dose, incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.
Interventions
- DRUG RG547
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00400296
The ClinicalTrials.gov registry entry for NCT00400296 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 58 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 RG547 is the first listed.
NCT00400296 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00400296 about?
NCT00400296 is a clinical study titled "A Study of R547 in Patients With Advanced Solid Tumors.". This single arm study will determine the maximum tolerated dose, and recommended dose for further development, of R547, in patients with advanced solid tumors. Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a) 90 minutes and b) 180 minutes, ...
What is the current status of trial NCT00400296?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2005-05. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00400296?
The interventions under investigation include: RG547 (DRUG).
Who is sponsoring clinical trial NCT00400296?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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