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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 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.

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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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2009-03
Est. Completion 2010-04
Phase Phase 2

Sponsor

Rigel Pharmaceuticals

22 total trials

What the Registry Record Tells You About NCT00798096

The ClinicalTrials.gov registry entry for NCT00798096 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 133-participant average among 15 other T-Cell Lymphoma trials with a reported enrollment target (86% lower). The listed sponsor is Rigel Pharmaceuticals, which has 22 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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