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NCT00798096 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma
A Phase 2 study of T-Cell Lymphoma, sponsored by Rigel Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 10
- Study locations
NCT00798096: Completed Phase 2 study of T-Cell Lymphoma, sponsored by Rigel Pharmaceuticals.
NCT00798096 is a Phase 2 study of T-Cell Lymphoma that has completed, run by Rigel Pharmaceuticals. The registered enrollment target is 18 participants, below the 133-participant average among 15 other T-Cell Lymphoma trials with a reported enrollment target (86% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00798096, a Phase 2 study of T-Cell Lymphoma, has completed, sponsored by Rigel Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 10
- Study locations
Study Summary
Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium until disease progression. Efficacy will be assessed by tumor measurements using CT and PET (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 8 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 30 days following last study drug treatment. Blood samples for PK assessment will be obtained from all patients enrolled in Stage 1 at protocol defined intervals.
Primary Outcome
Overall regressive response rate (ORRR) is the proportion of patients with a best response of Complete Response (CR), Partial Response (PR) (per Cheson 2007), or Regressive Stable Disease (RSD) defined as regressive disease that does not meet the criteria for partial response.
Conditions Studied
Interventions
- DRUG Fostamatinib Disodium
Study Locations (10)
California
- Research Site - San Francisco
- Research Site - Stanford
Georgia
- Research Site - Atlanta
Massachusetts
- Research Site - Boston
Minnesota
- Research Site - Rochester
Nebraska
- Research Site - Omaha
New York
- Research Site - New York
Texas
- Research Site - Houston
British Columbia
- Research Site - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00798096 record still lists
NCT00798096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 15 other T-Cell Lymphoma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with T-Cell Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Fostamatinib Disodium is the first listed.
NCT00798096 lists 10 locations in 9 states (California, Georgia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT00798096 about?
NCT00798096 is a clinical study titled "Efficacy and Safety Study of Fostamatinib Disodium Tablets to Treat T-Cell Lymphoma". Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 19 patients in Stage 1 and 36 patients in Stage 2. Stage 2 will enroll if 4 or more patients exhibit a response at Week 8 or later in the study. All enrolled patients will be treated with Fostamatinib Disodium...
What is the current status of trial NCT00798096?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2009-03. Estimated completion is 2010-04.
What conditions does trial NCT00798096 study?
This clinical trial studies the following conditions: T-Cell Lymphoma.
What interventions are being tested in trial NCT00798096?
The interventions under investigation include: Fostamatinib Disodium (DRUG).
Who is sponsoring clinical trial NCT00798096?
This trial is sponsored by Rigel Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00798096 being conducted?
This trial has 10 study locations across California, Georgia, Massachusetts, Minnesota, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00798096's enrollment target sits among peer trials
18 15th of 15 higher than 1 of 15 other T-Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other T-Cell Lymphoma 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.
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