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Cantor Fitzgerald
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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR ROMIDEPSIN

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Clinical Trials for Romidepsin

Trial ID Title Status Sponsor Phase Summary
NCT00007345 Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 2 Background: NSC630176 is a depsipeptide fermentation product from Chromobacterium violaceum with potent cytotoxic activity against human tumor cell lines and in vivo efficacy against both human tumor xenografts and murine tumors (1-3). NSC 630176, herein referred to as depsipeptide, shows a lack of cross resistance with several commonly used cytotoxic agents such as vincristine, 5-fluorouracil, mitomycin C and cyclophosphamide (2). However, it has been defined as a P-glycoprotein (Pgp) substrate by COMPARE analysis of the National Cancer Institute (NCI) drug screen cytotoxicity profile (4). Depsipeptide is a member of a novel class of antineoplastic agents, the histone deacetylase inhibitors. In the phase I trial conducted at the National Cancer Institute (NCI), responses were observed at the maximum tolerated dose (MTD) in patients with cutaneous and peripheral T-cell lymphoma. Objectives: In patients with cutaneous T-cell lymphoma, the primary end points to be examined are overall response rate, complete response rate and duration of response. In patients with relapsed peripheral T-cell lymphoma, the endpoints to be examined are overall response rate and complete response rate. To evaluate the tolerability of depsipeptide with extended cycles of therapy. Eligibility: Patients with cutaneous T-cell lymphoma (mycosis fungoides or Sezary syndrome) or other peripheral T-cell lymphomas are eligible. Design: Depsipeptide will be administered at 14 mg/m^2, over 4 hours on days 1, 8 and 15. This trial will accrue in six cohorts; Arm 1, patients with cutaneous T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 2, patients with peripheral T-cell lymphoma who have had less than or equal to two prior cytotoxic chemotherapy regimens; Arm 3, patients with cutaneous and peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 4, patients with other mature T-cell lymphomas; Arm 5, a replicate arm of arm 1; Arm 6, patients with peripheral T-cell lymphoma who have had more than two prior cytotoxic chemotherapy regimens; Arm 7, patients with cutaneous T cell lymphoma who have received vorinostat. Dose may be adjusted based on toxicities.
NCT00019318 Depsipeptide in Treating Patients With Solid Tumors Completed National Cancer Institute (NCI) Phase 1 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of depsipeptide in treating patients who have solid tumors for which no standard therapy exists.
NCT00024180 FR901228 in Treating Patients With Hematologic Cancer Completed National Cancer Institute (NCI) Phase 1 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.
NCT00024180 FR901228 in Treating Patients With Hematologic Cancer Completed Ohio State University Comprehensive Cancer Center Phase 1 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have hematologic cancer.
NCT00042822 FR901228 in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Non-Hodgkin's Lymphoma Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have myelodysplastic syndrome, acute myeloid leukemia, or non-Hodgkin's lymphoma.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Romidepsin

Condition Name

Condition Name for Romidepsin
Intervention Trials
Lymphoma 12
Cutaneous T-cell Lymphoma 6
Peripheral T-cell Lymphoma 6
Multiple Myeloma 6
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Condition MeSH

Condition MeSH for Romidepsin
Intervention Trials
Lymphoma 46
Lymphoma, T-Cell 35
Lymphoma, T-Cell, Peripheral 21
Lymphoma, T-Cell, Cutaneous 15
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Clinical Trial Locations for Romidepsin

Trials by Country

Trials by Country for Romidepsin
Location Trials
United States 188
Italy 32
Japan 19
United Kingdom 7
Canada 6
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Trials by US State

Trials by US State for Romidepsin
Location Trials
New York 19
California 17
Maryland 13
Texas 13
Illinois 12
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Clinical Trial Progress for Romidepsin

Clinical Trial Phase

Clinical Trial Phase for Romidepsin
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
Phase 2 29
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Clinical Trial Status

Clinical Trial Status for Romidepsin
Clinical Trial Phase Trials
Completed 28
Recruiting 23
Active, not recruiting 15
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Clinical Trial Sponsors for Romidepsin

Sponsor Name

Sponsor Name for Romidepsin
Sponsor Trials
National Cancer Institute (NCI) 30
Celgene Corporation 26
Celgene 7
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Sponsor Type

Sponsor Type for Romidepsin
Sponsor Trials
Other 79
Industry 47
NIH 31
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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
UBS
Accenture
US Army
Fish and Richardson
Argus Health
Chubb
Daiichi Sankyo
Boehringer Ingelheim

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