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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
-

Doxorubicin and Bortezomib in Treating Patients With Liver Cancer

Phase 2
Completed
Conditions
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Interventions
First Posted Date
2004-05-17
Last Posted Date
2014-10-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
42
Registration Number
NCT00083226
Locations
🇺🇸

Eastern Cooperative Oncology Group, Boston, Massachusetts, United States

PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma

Phase 1
Completed
Conditions
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2004-04-12
Last Posted Date
2012-11-09
Lead Sponsor
NYU Langone Health
Registration Number
NCT00004002
Locations
🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 2 locations

Repeat-Dose Pharmacokinetics and Pharmacodynamics of Bortezomib in Patients With Relapsed Multiple Myeloma

Phase 1
Completed
Conditions
Multiple Myeloma
First Posted Date
2004-04-02
Last Posted Date
2009-03-27
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
40
Registration Number
NCT00080405

PS-341 in Treating Patients With Hematologic Cancer

Phase 1
Completed
Conditions
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
First Posted Date
2004-03-17
Last Posted Date
2013-06-18
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00006098
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

Phase 2
Completed
Conditions
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
First Posted Date
2004-02-16
Last Posted Date
2013-01-31
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Registration Number
NCT00017199
Locations
🇺🇸

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

🇺🇸

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Bortezomib, Fluorouracil, and Leucovorin Calcium in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By Surgery

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug: bortezomib
Drug: fluorouracil
Drug: leucovorin calcium
Other: pharmacological study
Other: laboratory biomarker analysis
First Posted Date
2004-02-16
Last Posted Date
2013-12-11
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
30
Registration Number
NCT00007878
Locations
🇺🇸

University of Southern California, Los Angeles, California, United States

Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia

Phase 1
Completed
Conditions
Blastic Phase Chronic Myelogenous Leukemia
Childhood Acute Promyelocytic Leukemia (M3)
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Interventions
Drug: bortezomib
Other: pharmacological study
Other: laboratory biomarker analysis
First Posted Date
2004-02-12
Last Posted Date
2013-06-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
36
Registration Number
NCT00077467
Locations
🇺🇸

COG Phase I Consortium, Arcadia, California, United States

Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)

Phase 2
Completed
Conditions
Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Interventions
Drug: bortezomib
Other: laboratory biomarker analysis
First Posted Date
2004-02-12
Last Posted Date
2013-06-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
55
Registration Number
NCT00077441
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Bortezomib Followed by the Addition of Doxorubicin at Disease Progression in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma (Cancer) of the Head and Neck

Phase 2
Completed
Conditions
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Salivary Gland Cancer
Salivary Gland Adenoid Cystic Carcinoma
Stage III Adenoid Cystic Carcinoma of the Oral Cavity
Stage III Salivary Gland Cancer
Stage IV Adenoid Cystic Carcinoma of the Oral Cavity
Stage IV Salivary Gland Cancer
Interventions
Drug: bortezomib
Drug: doxorubicin hydrochloride
Other: laboratory biomarker analysis
First Posted Date
2004-02-12
Last Posted Date
2013-01-24
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
37
Registration Number
NCT00077428
Locations
🇺🇸

Eastern Cooperative Oncology Group, Boston, Massachusetts, United States

PS-341 in Treating Patients With Metastatic Malignant Melanoma

Phase 2
Completed
Conditions
Stage IV Melanoma
Recurrent Melanoma
Interventions
Drug: bortezomib
Other: laboratory biomarker analysis
First Posted Date
2004-02-06
Last Posted Date
2013-01-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
50
Registration Number
NCT00024011
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

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