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

S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: bortezomib
Drug: dexamethasone
Drug: thalidomide

First Posted Date: 2005-07-28

Last Posted Date: 2018-08-09

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 7

Registration Number: NCT00124579

Locations: 🇺🇸
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
🇺🇸
Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States
🇺🇸
St. James Healthcare Cancer Care, Butte, Montana, United States

and more 123 locations

Bortezomib in Treating Patients With Stage IIIB or Stage IV Lung Cancer

Phase 2

Completed

Conditions: Bronchoalveolar Cell Lung Cancer
Non-small Cell Lung Cancer
Adenocarcinoma of the Lung
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer

Interventions: Drug: bortezomib

First Posted Date: 2005-07-11

Last Posted Date: 2014-08-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 42

Registration Number: NCT00118144

Locations: 🇺🇸
City of Hope, Duarte, California, United States

Docetaxel With Either Cetuximab or Bortezomib as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Adenocarcinoma of the Lung
Adenosquamous Cell Lung Cancer
Large Cell Lung Cancer
Malignant Pleural Effusion
Recurrent Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer

Interventions: Drug: docetaxel
Biological: cetuximab
Drug: bortezomib

First Posted Date: 2005-07-11

Last Posted Date: 2013-06-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 62

Registration Number: NCT00118183

Locations: 🇺🇸
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States

Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

First Posted Date: 2005-07-01

Last Posted Date: 2012-02-07

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 40

Registration Number: NCT00116961

Locations: 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Lymphoma, Mantle Cell
Mantle Cell Lymphoma

Interventions: Drug: Bortezomib (B)
Drug: Bortezomib or observation
Drug: Rituximab (R)
Biological: EPOCH
Drug: Bortezomib

First Posted Date: 2005-06-17

Last Posted Date: 2022-10-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 53

Registration Number: NCT00114738

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: vorinostat
Drug: bortezomib

First Posted Date: 2005-05-26

Last Posted Date: 2015-05-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 34

Registration Number: NCT00111813

VELCADE/Melphalan/Prednisone Versus Melphalan/Prednisone in Patients With Previously Untreated Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

First Posted Date: 2005-05-20

Last Posted Date: 2009-03-26

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Registration Number: NCT00111319

Locations: 🇺🇸
Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana, United States

Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors

Phase 2

Completed

Conditions: Glioma

Interventions: Drug: Tamoxifen citrate
Drug: Bortezomib

First Posted Date: 2005-04-13

Last Posted Date: 2015-11-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 43

Registration Number: NCT00108069

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Unresectable, Metastatic Cancer of the Esophagus or Gastroesophageal Junction

Phase 2

Completed

Conditions: Esophageal Cancer

Interventions: Drug: bortezomib
Drug: carboplatin
Drug: paclitaxel

First Posted Date: 2005-04-06

Last Posted Date: 2016-12-13

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 37

Registration Number: NCT00107341

Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

Phase 2

Completed

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

Interventions: Drug: Bortezomib

First Posted Date: 2005-03-04

Last Posted Date: 2018-12-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT00104871

Locations: 🇺🇸
Lombardi Comprehensive Cancer Center at Georgetown University, Washington, District of Columbia, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

and more 6 locations

Drug Development Updates

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