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NCT00446095 · ClinicalTrials.gov registry record · Phase 1
Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma
A Phase 1 study, sponsored by Rigel Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT00446095: Completed Phase 1 study, sponsored by Rigel Pharmaceuticals.
NCT00446095 is a Phase 1 study that has completed, run by Rigel Pharmaceuticals. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00446095, a Phase 1 study, has completed, sponsored by Rigel Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
Patients: B-cell lymphoma, refractory, diffuse, nodular, mantle, other Phase I : Two groups of 6 patients, escalating dose tolerability- 28 days Phase II: Three groups of 16 patients (nodular, diffuse large cell, mantle cell plus others). Oral bid dosing with highest tolerable dose until toxicity, progression, or withdrawal
Primary Outcome
Proportion of patients with Complete Response (CR) or Partial Response (PR). Revised Response Criteria for Malignant Lymphoma categorises the response of the treatment of a patient's tumour to; CR: the disappearance of all evidence of disease; PR: ≥ 50% decrease in the sum of the perpendicular diameters (SPD) of the six largest dominant nodes plus no increase in the size of other nodes and no new sites of disease; Stable Disease (SD): less than a PR but not progressive disease; Relapsed Disease
Interventions
- DRUG fostamatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
What the finished NCT00446095 record still lists
NCT00446095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which fostamatinib is the first listed.
NCT00446095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00446095 about?
NCT00446095 is a clinical study titled "Efficacy and Safety Study of Fostamatinib Tablets to Treat B-cell Lymphoma". Patients: B-cell lymphoma, refractory, diffuse, nodular, mantle, other Phase I : Two groups of 6 patients, escalating dose tolerability- 28 days Phase II: Three groups of 16 patients (nodular, diffuse large cell, mantle cell plus others). Oral bid dosing with highest tolerable dose until toxicity, p...
What is the current status of trial NCT00446095?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2007-04. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00446095?
The interventions under investigation include: fostamatinib (DRUG).
Who is sponsoring clinical trial NCT00446095?
This trial is sponsored by Rigel Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00446095's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 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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