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Sponsored by: |
Gloucester Pharmaceuticals |
Information provided by: | Gloucester Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00426764 |
The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.
Patients will receive romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.
The planned duration of study treatment is 6 cycles or until disease progression occurs.
Condition | Intervention | Phase |
Peripheral T-Cell Lymphoma |
Drug: romidepsin |
Phase II |
MedlinePlus related topics: | Lymphoma |
ChemIDplus related topics: | FR 901228 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Open-Label Trial Evaluating the Activity and Tolerability of Romidepsin (Depsipeptide, FK228) in Progressive or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy |
Estimated Enrollment: | 65 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Patients will receive romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.
The planned duration of study treatment is 6 cycles or until disease progression occurs.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must fulfill all of the following criteria to be eligible for study participation and have:
Exclusion Criteria:
Patients are ineligible for entry if any of the following criteria are met:
Any known cardiac abnormalities such as:
Inadequate bone marrow or other organ function as evidenced by:
Contact: Susan Carroll | 617 583 1348 | sbcarroll05@gmail.com |
Show 55 Study Locations |
Gloucester Pharmaceuticals |
Study Director: | Jean Nichols, Ph.D. | Gloucester Pharmaceuticals, Inc. |
Responsible Party: | Gloucester Pharmaceuticals, Inc. ( Jean Nichols, Ph.D., President and Chief Operating Officer ) |
Study ID Numbers: | GPI-06-0002 |
First Received: | January 23, 2007 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00426764 |
Health Authority: | United States: Food and Drug Administration |
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