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NCT00400361 · ClinicalTrials.gov registry record · Phase 1
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
NCT00400361 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 98 participants.
The verdict
NCT00400361, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
Study Summary
This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics 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 individuals.
Interventions
- DRUG RG1507
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2006-04 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00400361
The ClinicalTrials.gov registry entry for NCT00400361 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 98 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.
NCT00400361 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00400361 about?
NCT00400361 is a clinical study titled "A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.". This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either ...
What is the current status of trial NCT00400361?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2006-04. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00400361?
The interventions under investigation include: RG1507 (DRUG).
Who is sponsoring clinical trial NCT00400361?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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