MedPath

Vinorelbine

Generic Name
Vinorelbine
Drug Type
Small Molecule
Chemical Formula
C45H54N4O8
CAS Number
71486-22-1
Unique Ingredient Identifier
Q6C979R91Y
Background

Vinorelbine is an anti-mitotic chemotherapy drug that is used in the treatment of several types of malignancies, including breast cancer and non-small cell lung cancer (NSCLC) . It was initially approved in the USA in 1990's for the treatment of NSCLC .

It is a third-generation vinca alkaloid. The introduction of third-generation drugs (vinorelbine, gemcitabine, taxanes) in platinum combination improved survival of patients with advanced NSCLC, with very similar results from the various drugs. Treatment toxicities are considerable in the combination treatment setting .

A study was done on the clearance rate of vinorelbine on individuals with various single polymorphonuclear mutations. It was found that there was 4.3-fold variation in vinorelbine clearance across the cohort, suggesting a strong influence of genetics on the clearance of this drug .

Indication

Vinorelbine tartrate is indicated for adults in the treatment of advanced non-small cell lung cancer (NSCLC), as a single therapy or in combination with other chemotherapeutic drugs .

Used in relapsed or refractory Hodgkin lymphoma, in combination with other chemotherapy agents .

For the treatment of desmoid tumor or aggressive fibromatosis, in combination with methotrexate .

For the treatment of recurrent or metastatic squamous cell head and neck cancer .

For the treatment of recurrent ovarian cancer .

For the treatment of metastatic breast cancer, in patients previously treated with anthracyline and/or taxane therapy .

For the treatment of HER2-positive, trastuzumab-resistant, advanced breast cancer in patients previously treated with a taxane, in combination with trastuzumab and everolimus .

Associated Conditions
Locally Advanced Non-Small Cell Lung Cancer, Metastatic Breast Cancer, Metastatic Cervical Cancer, Metastatic Non-Small Cell Lung Cancer, Recurrent Cervical Cancer, Soft Tissue Sarcoma

Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
First Posted Date
2005-09-12
Last Posted Date
2013-02-07
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
40
Registration Number
NCT00153907
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

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

Preoperative Herceptin and Navelbine for Breast Cancer

Phase 2
Completed
Conditions
Stage III Breast Cancer
Breast Cancer
Stage II Breast Cancer
Interventions
First Posted Date
2005-09-08
Last Posted Date
2019-01-15
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
49
Registration Number
NCT00148681
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

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

🇺🇸

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

Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2005-09-08
Last Posted Date
2013-04-09
Lead Sponsor
Eric Winer, MD
Target Recruit Count
81
Registration Number
NCT00148668
Locations
🇺🇸

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

🇺🇸

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

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 1 locations

Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy.

Phase 3
Completed
Conditions
Non-Small-Cell Lung Carcinoma
First Posted Date
2005-09-08
Last Posted Date
2008-04-22
Lead Sponsor
Aktion Bronchialkarzinom e.V.
Target Recruit Count
280
Registration Number
NCT00148395
Locations
🇩🇪

Klinikum Kassel GmbH, Kassel, Germany

Oral Estramustine and Oral Vinorelbine in the Treatment of Hormone-Refractory Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-09-08
Last Posted Date
2015-01-22
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
33
Registration Number
NCT00151086
Locations
🇺🇸

The University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Stage IV Breast Cancer
First Posted Date
2005-09-07
Last Posted Date
2009-11-01
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
250
Registration Number
NCT00146549
Locations
🇺🇸

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

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

A Phase I/II Study of ABI-007 (Abraxane®, Nab®-Paclitaxel)and Vinorelbine in Patients With Stage IV (Metastatic) Breast Cancer

Phase 1
Terminated
Conditions
Stage IV (Metastatic) Breast Cancer
Interventions
First Posted Date
2005-09-01
Last Posted Date
2019-11-26
Lead Sponsor
Celgene
Target Recruit Count
16
Registration Number
NCT00140140
Locations
🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

🇺🇸

City of Hope Comprehensive Cancer Care Center, Duarte, California, United States

Study of Gemcitabine and Vinorelbine in Soft Tissue Sarcomas

Phase 2
Completed
Conditions
Sarcoma, Soft Tissue
First Posted Date
2005-08-25
Last Posted Date
2007-12-21
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
40
Registration Number
NCT00134641
Locations
🇺🇸

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

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2005-08-15
Last Posted Date
2019-02-26
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
14
Registration Number
NCT00130507
Locations
🇪🇸

Spanish Breast Cancer Research Group (GEICAM), San Sebastián de los Reyes, Madrid, Spain

Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

Phase 3
Completed
Conditions
Breast Cancer
Neoplasm Metastasis
Interventions
First Posted Date
2005-08-09
Last Posted Date
2023-05-31
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
252
Registration Number
NCT00128310
Locations
🇪🇸

Spanish Breast Cancer Research Group (GEICAM), San Sebastián de los Reyes, Madrid, Spain

🇻🇪

Grupo Andino de Investigación en Oncología (GAICO), Valencia, Venezuela

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