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Bortezomib

Generic Name
Bortezomib
Brand Names
Velcade, Bortezomib Accord, Bortezomib Hospira, Bortezomib Fresenius Kabi, Bortezomib Sun
Drug Type
Small Molecule
Chemical Formula
C19H25BN4O4
CAS Number
179324-69-7
Unique Ingredient Identifier
69G8BD63PP
Background

Bortezomib is a dipeptide boronic acid derivative and proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma. The 26S proteasome is a protein complex that degrades ubiquitinated proteins in the ubiquitin-proteasome pathway: reversible inhibition of the 26S proteasome, leading to cell cycle arrest and apoptosis of cancer cells, is thought to be the main mechanism of action of bortezomib. However, multiple mechanisms may be involved in the anticancer activity of bortezomib.

Bortezomib was first synthesized in 1995. In May 2003, bortezomib became the first anticancer proteasome inhibitor that was approved by the FDA under the trade name VELCADE. Phase I, II, III, and IV clinical trials are undergoing to investigate the therapeutic efficacy of bortezomib in leukemia, myasthenia gravis, systemic lupus erythematosus, rheumatoid arthritis, and solid tumours.

Indication

Bortezomib is indicated for the treatment of adults with multiple myeloma or mantle cell lymphoma.

Associated Conditions
Mantle Cell Lymphoma (MCL), Multiple Myeloma (MM)
Associated Therapies
-

Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer

Phase 2
Terminated
Conditions
Gastric Cancer
First Posted Date
2005-02-08
Last Posted Date
2010-10-13
Lead Sponsor
California Cancer Consortium
Registration Number
NCT00103103
Locations
🇺🇸

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

🇺🇸

City of Hope Medical Group, Pasadena, California, United States

🇺🇸

University of California Davis Cancer Center, Sacramento, California, United States

and more 2 locations

Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 2
Completed
Conditions
Recurrent Verrucous Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IVA Verrucous Carcinoma of the Oral Cavity
Interventions
Drug: bortezomib
Drug: irinotecan hydrochloride
Other: laboratory biomarker analysis
First Posted Date
2005-02-08
Last Posted Date
2014-05-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
71
Registration Number
NCT00103259
Locations
🇺🇸

Eastern Cooperative Oncology Group, Boston, Massachusetts, United States

17-N-Allylamino-17-Demethoxygeldanamycin and Bortezomib in Treating Patients With Relapsed or Refractory Hematologic Cancer

Phase 1
Terminated
Conditions
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Interventions
First Posted Date
2005-02-08
Last Posted Date
2013-06-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
74
Registration Number
NCT00103272
Locations
🇺🇸

Ohio State University Medical Center, Columbus, Ohio, United States

Bortezomib, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Advanced or Metastatic Colorectal Cancer

Phase 1
Completed
Conditions
Colorectal Cancer
First Posted Date
2004-12-09
Last Posted Date
2013-06-12
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
16
Registration Number
NCT00098982
Locations
🇨🇭

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

🇬🇧

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

🇮🇹

Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples, Italy

Tanespimycin and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

Phase 1
Terminated
Conditions
Adult Grade III Lymphomatoid Granulomatosis
AIDS-related Peripheral/Systemic Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Interventions
Drug: tanespimycin
Drug: bortezomib
Other: laboratory biomarker analysis
First Posted Date
2004-11-09
Last Posted Date
2014-02-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
36
Registration Number
NCT00096005
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Bortezomib, Paclitaxel, Carboplatin and Radiation Therapy for Non-Small Cell Lung Cancer

Phase 1
Completed
Conditions
Stage IIIB Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Interventions
Radiation: 3-dimensional conformal radiation therapy
Drug: bortezomib
Drug: paclitaxel
Drug: carboplatin
First Posted Date
2004-10-08
Last Posted Date
2017-12-07
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
52
Registration Number
NCT00093756
Locations
🇺🇸

Mcdonough District Hospital, Macomb, Illinois, United States

🇺🇸

Carle Foundation - Carle Cancer Center, Urbana, Illinois, United States

🇺🇸

Siouxland Regional Cancer Center, Sioux City, Iowa, United States

and more 139 locations

Study of Bortezomib and Revlimid™ for Patients Relapsing or Progressing on Total Therapy II

Phase 3
Completed
Conditions
Multiple Myeloma
First Posted Date
2004-10-01
Last Posted Date
2010-07-02
Lead Sponsor
University of Arkansas
Target Recruit Count
315
Registration Number
NCT00093028
Locations
🇺🇸

University of Arkansas for Medical Sciences/MIRT, Little Rock, Arkansas, United States

Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity

First Posted Date
2004-09-22
Last Posted Date
2024-12-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
75
Registration Number
NCT00092222
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Bortezomib in Treating Patients With Advanced Cancer and Liver Dysfunction

Phase 1
Completed
Conditions
Hepatic Complications
Malignant Neoplasm
Interventions
Drug: bortezomib
Other: pharmacological study
First Posted Date
2004-09-08
Last Posted Date
2013-12-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
80
Registration Number
NCT00091117
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Wayne State University, Detroit, Michigan, United States

Bortezomib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Previously Untreated Symptomatic Multiple Myeloma

Phase 2
Completed
Conditions
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
DS Stage I Plasma Cell Myeloma
Interventions
First Posted Date
2004-08-05
Last Posted Date
2019-09-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
55
Registration Number
NCT00088855
Locations
🇺🇸

Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States

🇺🇸

Danville Regional Medical Center, Danville, Virginia, United States

🇺🇸

Frisbie Hospital, Rochester, New Hampshire, United States

and more 22 locations
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