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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
-

PS-341 in Treating Women With Metastatic Breast Cancer

Phase 2
Completed
Conditions
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions
Drug: bortezomib
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2013-01-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
35
Registration Number
NCT00025584
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Phase 1
Completed
Conditions
Malignant Pleural Effusion
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions
First Posted Date
2003-01-27
Last Posted Date
2013-01-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
34
Registration Number
NCT00052338
Locations
🇺🇸

City of Hope, Duarte, California, United States

PS-341 and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug: bortezomib
Drug: paclitaxel
Drug: carboplatin
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2013-01-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
96
Registration Number
NCT00028587
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Phase 2
Completed
Conditions
Recurrent Ovarian Epithelial Cancer
Primary Peritoneal Cavity Cancer
Interventions
Drug: bortezomib
Other: laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2003-01-27
Last Posted Date
2019-07-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
58
Registration Number
NCT00023712
Locations
🇺🇸

Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer

Phase 2
Completed
Conditions
Colorectal Cancer
First Posted Date
2003-01-27
Last Posted Date
2015-07-23
Lead Sponsor
University Health Network, Toronto
Registration Number
NCT00052507
Locations
🇨🇦

Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada

🇨🇦

Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada

🇨🇦

Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada

and more 1 locations

Bortezomib in Treating Patients With Advanced Non-small Cell Lung Cancer

Phase 2
Terminated
Conditions
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions
First Posted Date
2003-01-27
Last Posted Date
2013-01-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
35
Registration Number
NCT00040768
Locations
🇺🇸

Abramson Cancer Center of The University of Pennsylvania, Philadelphia, Pennsylvania, United States

Bortezomib With or Without Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer

Phase 2
Completed
Conditions
Duct Cell Adenocarcinoma of the Pancreas
Stage IV Pancreatic Cancer
Interventions
First Posted Date
2003-01-27
Last Posted Date
2013-10-08
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
88
Registration Number
NCT00052689
Locations
🇺🇸

North Central Cancer Treatment Group, Rochester, Minnesota, United States

PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Phase 3
Completed
Conditions
Multiple Myeloma
First Posted Date
2002-10-30
Last Posted Date
2012-01-13
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
620
Registration Number
NCT00048230
Locations
🇺🇸

Kaiser Permanente Oncology Clinical Trials, Vallejo, California, United States

🇺🇸

Texas Oncology at Medical City Dallas Hospital, Dallas, Texas, United States

🇺🇸

Western Pennsylvania Hospital, Dept. of Human Oncology, Pittsburgh, Pennsylvania, United States

and more 90 locations

PS-341 and Radiation to Treat Advanced Cancer of the Head and Neck

Phase 1
Completed
Conditions
Squamous Cell Carcinoma
First Posted Date
2001-03-01
Last Posted Date
2019-12-12
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
25
Registration Number
NCT00011778
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
Drug: Myeloma Immunoglobulin Idiotype Vaccine
Drug: Bortezomib
Drug: Cyclophosphamide
Biological: GMCSF (granulocyte macrophage colony stimulating factor)
Drug: Cyclosporine
Drug: Doxorubicin hydrochloride
Drug: Etoposide
Drug: Fludarabine phosphate
Drug: Prednisone
Drug: Vincristine Sulfate
Drug: Methotrexate
Biological: GCSF (granulocyte colony stimulating factor)
First Posted Date
2000-08-24
Last Posted Date
2017-10-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
20
Registration Number
NCT00006184
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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