Romidepsin

Generic Name: Romidepsin

Brand Names: Istodax

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₃₆N_₄O_₆S_₂

CAS Number: 128517-07-7

Unique Ingredient Identifier: CX3T89XQBK

Background: Romidepsin is a selective inhibitor of histone deacetylase, approved in the US in 2009 for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

Indication: 用于在已接受至少1次既往全身治疗的患者中皮肤T-细胞淋巴瘤的治疗(CTCL)。

Associated Conditions: Cutaneous T-Cell Lymphoma (CTCL)

Associated Therapies: -

Clinical Trials

Influence of Rifampin on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer

Phase 1

Completed

Conditions: Hematologic Malignancy
Malignant Lymphoma

Interventions: Drug: Romidepsin
Drug: Rifampin

First Posted Date: 2011-03-29

Last Posted Date: 2019-11-25

Lead Sponsor: Celgene

Target Recruit Count: 14

Registration Number: NCT01324323

Locations: 🇬🇧
Sarah Cannon Research UK, London, United Kingdom
🇺🇸
Sarah Canon Research Institute, Nashville, Tennessee, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States

Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 1

Completed

Conditions: Leukemia
Lymphoma

Interventions: Drug: Bortezomib
Drug: Romidepsin

First Posted Date: 2009-08-21

Last Posted Date: 2018-04-23

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 18

Registration Number: NCT00963274

Locations: 🇺🇸
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
🇺🇸
University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States

and more 2 locations

Trial of Romidepsin and Bortezomib for Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Romidepsin

First Posted Date: 2008-10-02

Last Posted Date: 2019-11-25

Lead Sponsor: Celgene

Target Recruit Count: 32

Registration Number: NCT00765102

Locations: 🇺🇸
Loma Linda University Cancer Center, Loma Linda, California, United States
🇺🇸
Santa Barbara Hematology Oncology Medical Group, Inc., Santa Barbara, California, United States
🇺🇸
Desert Cancer Care, Inc, Rancho Mirage, California, United States

and more 9 locations

A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma

Phase 2

Completed

Conditions: Peripheral T-cell Lymphoma

Interventions: Drug: Romidepsin

First Posted Date: 2007-01-25

Last Posted Date: 2020-02-11

Lead Sponsor: Celgene

Target Recruit Count: 131

Registration Number: NCT00426764

Locations: 🇺🇸
Hematology Oncology Assoc. of IL Orchard Research LLC, Chicago, Illinois, United States
🇩🇪
Charite Universitatsmedizin Berlin campus Virchow Klinikum Centrum fur Tumormedizin, Berlin, Germany
🇪🇸
Hospital Universitario Vall D Hebron, Barcelona, Spain

and more 87 locations

FR901228 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 2

Terminated

Conditions: Recurrent Mantle Cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma

Interventions: Drug: romidepsin

First Posted Date: 2006-10-03

Last Posted Date: 2014-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 9

Registration Number: NCT00383565

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors

Phase 1

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Romidepsin
Drug: Gemcitabine

First Posted Date: 2006-09-22

Last Posted Date: 2019-10-30

Lead Sponsor: Celgene

Target Recruit Count: 36

Registration Number: NCT00379639

Locations: 🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States

Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders

Phase 1

Completed

Conditions: Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms

Interventions: Drug: decitabine
Drug: romidepsin

First Posted Date: 2005-06-14

Last Posted Date: 2013-02-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 36

Registration Number: NCT00114257

Locations: 🇺🇸
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States

Depsipeptide (Romidepsin) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma

Phase 2

Completed

Conditions: Adult Extraskeletal Osteosarcoma
Adult Malignant Mesenchymoma
Adult Extraskeletal Chondrosarcoma
Adult Fibrosarcoma
Adult Alveolar Soft-part Sarcoma
Adult Angiosarcoma
Adult Leiomyosarcoma
Adult Liposarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Interventions: Drug: romidepsin

First Posted Date: 2005-06-03

Last Posted Date: 2017-06-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 40

Registration Number: NCT00112463

A Research Study for Patients With Prostate Cancer

Phase 2

Completed

Conditions: Metastases
Prostate Cancer

Interventions: Drug: Romidepsin

First Posted Date: 2005-03-25

Last Posted Date: 2019-11-18

Lead Sponsor: Celgene

Target Recruit Count: 35

Registration Number: NCT00106418

Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine

Phase 2

Completed

Conditions: Recurrent Thyroid Cancer
Stage IV Follicular Thyroid Cancer
Stage IV Papillary Thyroid Cancer

Interventions: Drug: romidepsin
Other: laboratory biomarker analysis
Procedure: positron emission tomography

First Posted Date: 2004-12-09

Last Posted Date: 2014-05-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT00098813

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center at Suffolk, Commack, New York, United States

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