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 in Treating Patients With Advanced or Metastatic Transitional Cell Cancer of the Bladder, Renal Pelvis, or Ureter

Phase 2

Completed

Conditions: Transitional Cell Cancer of the Renal Pelvis and Ureter
Bladder Cancer

First Posted Date: 2003-08-07

Last Posted Date: 2015-07-23

Lead Sponsor: University Health Network, Toronto

Registration Number: NCT00066352

Locations: 🇨🇦
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
🇺🇸
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada

and more 12 locations

A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039

Phase 3

Completed

Conditions: Multiple Myeloma

First Posted Date: 2003-07-11

Last Posted Date: 2012-01-13

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 600

Registration Number: NCT00063726

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Texas Oncology at Medical City Dallas Hospital, Dallas, Texas, United States
🇺🇸
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States

and more 73 locations

Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: bortezomib
Drug: docetaxel

First Posted Date: 2003-07-09

Last Posted Date: 2019-12-13

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 4

Registration Number: NCT00064012

Locations: 🇺🇸
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
🇺🇸
Siteman Cancer Center, Saint Louis, Missouri, United States
🇺🇸
St. Louis University Hospital Cancer Center, Saint Louis, Missouri, United States

and more 18 locations

A Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE

Conditions: Multiple Myeloma

First Posted Date: 2003-07-08

Last Posted Date: 2007-02-14

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Registration Number: NCT00063791

Locations: 🇺🇸
Henry Ford Health System, Detroit, Michigan, United States
🇺🇸
Michael Meshad, Oncology Center, Mobile, Alabama, United States
🇺🇸
Toledo Clinic, Toledo, Ohio, United States

Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach

Phase 2

Completed

Conditions: Adenocarcinoma of the Gastroesophageal Junction
Recurrent Gastric Cancer
Intestinal Adenocarcinoma of the Stomach
Mixed Adenocarcinoma of the Stomach
Stage IIIC Gastric Cancer
Diffuse Adenocarcinoma of the Stomach
Stage IIIB Gastric Cancer
Stage IV Gastric Cancer

Interventions: Drug: bortezomib
Drug: irinotecan

First Posted Date: 2003-06-06

Last Posted Date: 2021-02-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 41

Registration Number: NCT00061932

Locations: 🇺🇸
Montefiore Medical Center, Bronx, New York, United States

Bortezomib and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: bortezomib
Drug: paclitaxel
Other: laboratory biomarker analysis

First Posted Date: 2003-04-09

Last Posted Date: 2013-06-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 45

Registration Number: NCT00030368

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States

Bortezomib in Treating Patients With Advanced Cancer and Kidney Dysfunction

Phase 1

Completed

Conditions: Adult Grade III Lymphomatoid Granulomatosis
Adult Nasal Type Extranodal NK/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
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma

Interventions: Drug: bortezomib
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2003-02-06

Last Posted Date: 2013-05-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 69

Registration Number: NCT00054483

Locations: 🇺🇸
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

Phase 2

Completed

Conditions: Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-05-17

Lead Sponsor: NCIC Clinical Trials Group

Target Recruit Count: 27

Registration Number: NCT00045695

Locations: 🇨🇦
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
🇺🇸
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇨🇦
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada

and more 9 locations

Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma

Phase 2

Completed

Conditions: Sarcoma

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-06

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00027716

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States
🇺🇸
University of Chicago Cancer Research Center, New York, New York, United States

and more 3 locations

PS-341 in Treating Patients With Advanced Cancer

Phase 1

Completed

Conditions: Lymphoma
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous Condition
Unspecified Adult Solid Tumor, Protocol Specific

First Posted Date: 2003-01-27

Last Posted Date: 2011-08-03

Lead Sponsor: Mayo Clinic

Registration Number: NCT00006362

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy