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

A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

Phase 3
Withdrawn
Conditions
Advanced Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2019-01-22
Last Posted Date
2019-11-26
Lead Sponsor
iOMEDICO AG
Registration Number
NCT03811418
Locations
🇩🇪

iOMEDICO AG, Freiburg, Baden-Wuerttemberg, Germany

Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2019-01-11
Last Posted Date
2022-05-12
Lead Sponsor
University Hospital, Brest
Target Recruit Count
80
Registration Number
NCT03801304
Locations
🇫🇷

CH Aix en Provence, Aix-en-Provence, France

🇫🇷

CLCC Caen, Caen, France

🇫🇷

CH de Créteil, Créteil, France

and more 10 locations

An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease

Phase 2
Withdrawn
Conditions
Circulating Tumor DNA
Non-Small Cell Lung Cancer
Non-Small-Cell Lung Carcinoma
Interventions
First Posted Date
2018-12-10
Last Posted Date
2022-03-24
Lead Sponsor
Bristol-Myers Squibb
Registration Number
NCT03770299

Capecitabine Versus Vinorelbine in High Risk Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy

Phase 2
Not yet recruiting
Conditions
Pathologic Residual Cancer Cells
Interventions
Drug: Capecitabine, Oral, 500 Mg
First Posted Date
2018-10-12
Last Posted Date
2018-10-12
Lead Sponsor
Zhiyong Yu
Target Recruit Count
200
Registration Number
NCT03703427
Locations
🇨🇳

Zhiyong Yu, Jinan, Shandong, China

To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma

Phase 3
Conditions
NSCLC
EGFR
Interventions
First Posted Date
2018-09-04
Last Posted Date
2018-09-04
Lead Sponsor
Shenzhen People's Hospital
Target Recruit Count
48
Registration Number
NCT03656393
Locations
🇨🇳

Shenzhen People's Hospital, Shenzhen, Guangdong, China

Study of Re-irradiation at Relapse Versus RT and Multiple Elective rt Courses

Phase 2
Active, not recruiting
Conditions
Diffuse Intrinsic Pontine Glioma
Interventions
First Posted Date
2018-08-08
Last Posted Date
2023-12-06
Lead Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Target Recruit Count
54
Registration Number
NCT03620032
Locations
🇮🇹

Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

Phase 2
Recruiting
Conditions
Hodgkin Lymphoma
Relapsed or Refractory Hodgkin Lymphoma
Interventions
First Posted Date
2018-08-07
Last Posted Date
2024-12-18
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
257
Registration Number
NCT03618550
Locations
🇺🇸

University of Miami, Miami, Florida, United States

🇺🇸

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 5 locations

Vinorelbine in Advanced BRAF-like Colon Cancer

Phase 2
Conditions
Colon Cancer
Interventions
First Posted Date
2018-03-29
Last Posted Date
2018-08-27
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
82
Registration Number
NCT03482362
Locations
🇳🇱

Antoni van Leeuwenhoek, Amsterdam, Noord-Holland, Netherlands

A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer

Phase 3
Active, not recruiting
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2018-03-07
Last Posted Date
2025-04-22
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
257
Registration Number
NCT03456076
Locations
🇷🇺

Pavlov First Saint Petersburg State Medical University, St. Petersburg, Sankt Petersburg, Russian Federation

🇷🇺

Scientific Research Oncology Institute named after N.N. Petrov; Oncology, St. Petersburg, Sankt Petersburg, Russian Federation

🇷🇺

GUZ Regional clinical hospital # 1, Krasnodar, Russian Federation

and more 140 locations

Chemotherapy and G-CSF for Mobilization

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2018-02-22
Last Posted Date
2025-03-28
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
137
Registration Number
NCT03442673
Locations
🇨🇭

Department for Medical Oncology University Hospital/Inselspital, Berne, Switzerland

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