Bortezomib

Generic Name: Bortezomib

Brand Names: Velcade, Bortezomib Accord, Bortezomib Hospira, Bortezomib Fresenius Kabi, Bortezomib Sun

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₅BN_₄O_₄

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: -

Clinical Trials

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

Phase 2

Active, not recruiting

Conditions: Lymphoproliferative Disorder
HIV
HHV-8
Malignancy

Interventions: Drug: Etoposide
Drug: Interferon-alpha
Other: Observation Only
Drug: Sirolimus
Drug: Zidovudine
Drug: Rituximab
Drug: Bortezomib
Drug: Doxorubicin
Drug: Liposomal Doxorubicin
Drug: Valganciclovir
Drug: Vincristine
Drug: Cyclophosphamide
Drug: Filgrastim (G-CSF)
Drug: Prednisone

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: Drug: Bortezomib
Other: Laboratory Biomarker Analysis
Drug: Pegylated Liposomal Doxorubicin Hydrochloride

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

Adjuvant Bortezomib Maintenance Therapy After Autologous Peripheral Stem Cell Transplantation in Treating Patients With Intermediate or Advanced Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Interventions: Drug: bortezomib

First Posted Date: 2004-06-11

Last Posted Date: 2020-08-17

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 30

Registration Number: NCT00084747

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States

Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder

Phase 2

Terminated

Conditions: Localized Unresectable Adult Primary Liver Cancer
Advanced Adult Primary Liver Cancer
Gastrointestinal Cancer
Adenocarcinoma of the Extrahepatic Bile Duct
Recurrent Adult Primary Liver Cancer
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Adenocarcinoma of the Gallbladder
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer

Interventions: Drug: bortezomib

First Posted Date: 2004-06-11

Last Posted Date: 2017-07-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT00085410

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Bortezomib and Flavopiridol in Treating Patients With Recurrent or Refractory Indolent B-Cell Neoplasms

Phase 1

Completed

Conditions: Refractory Plasma Cell Myeloma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma
Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma

Interventions: Drug: Bortezomib
Drug: Alvocidib Hydrochloride
Other: Pharmacological Study

First Posted Date: 2004-05-19

Last Posted Date: 2014-12-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 93

Registration Number: NCT00082784

Locations: 🇺🇸
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

and more 2 locations

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