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NCT00532090 · ClinicalTrials.gov registry record · Phase 1
A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT00532090 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 110 participants.
The verdict
NCT00532090, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study Summary
This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.
Interventions
- DRUG RG4733
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00532090
The ClinicalTrials.gov registry entry for NCT00532090 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 110 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 RG4733 is the first listed.
NCT00532090 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00532090 about?
NCT00532090 is a clinical study titled "A Multiple Ascending Dose Study of R4733 in Patients With Advanced Solid Tumors.". This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administer...
What is the current status of trial NCT00532090?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2007-11. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00532090?
The interventions under investigation include: RG4733 (DRUG).
Who is sponsoring clinical trial NCT00532090?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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