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 of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer

Phase 1
Recruiting
Conditions
Recurrent Breast Cancer
Metastatic Breast Cancer
Advanced Malignancies
Interventions
First Posted Date
2024-01-11
Last Posted Date
2024-03-12
Lead Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Target Recruit Count
154
Registration Number
NCT06202261
Locations
🇨🇳

Affiliated Cancer Hospital of Chongqing University, Chongqing, Chongqing, China

🇨🇳

Affiliated cancer hospital of harbin medical university, Harbin, Heilongjiang, China

Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer

First Posted Date
2023-11-22
Last Posted Date
2024-11-28
Lead Sponsor
Shanghai Yizhong Pharmaceutical Co., Ltd.
Target Recruit Count
168
Registration Number
NCT06143553
Locations
🇨🇳

Jiangsu province Hospital, Nanjing, Jiangsu, China

🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Trotabresib in Combination With Vinorelbine and Radiation Therapy for the Treatment of HER2+ Breast Cancer With Central Nervous System or Leptomeningeal Metastasis

Phase 1
Withdrawn
Conditions
Breast Carcinoma
Metastatic Malignant Neoplasm in the Leptomeninges
Metastatic Malignant Neoplasm in the Brain
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Radiation: Radiation Therapy
Procedure: Resection
First Posted Date
2023-11-18
Last Posted Date
2024-04-01
Lead Sponsor
Northwestern University
Registration Number
NCT06137651
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer

Phase 3
Completed
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2023-10-30
Last Posted Date
2023-10-30
Lead Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.
Target Recruit Count
570
Registration Number
NCT06107790
Locations
🇨🇳

Jiangsu Province People's Hospital (First Affiliated Hospital of Nanjing Medical University), Nanjing, Jiangsu, China

Organoid-based Functional Precision Therapy for Advanced Breast Cancer

Phase 2
Recruiting
Conditions
HER2-negative Breast Cancer
Advanced Breast Cancer
Interventions
First Posted Date
2023-10-26
Last Posted Date
2024-11-25
Lead Sponsor
Guangdong Provincial People's Hospital
Target Recruit Count
252
Registration Number
NCT06102824
Locations
🇨🇳

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

Phase 3
Recruiting
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2023-10-13
Last Posted Date
2024-12-12
Lead Sponsor
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Target Recruit Count
376
Registration Number
NCT06081959
Locations
🇨🇳

Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, China

JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

First Posted Date
2023-10-12
Last Posted Date
2023-10-12
Lead Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Target Recruit Count
400
Registration Number
NCT06079983
Locations
🇨🇳

Jilin Provincial Cancer Hospital, Changchun, China

🇨🇳

Guangdong Provincial People's Hospital, Guangzhou, China

🇨🇳

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China

and more 47 locations

Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease

Phase 2
Recruiting
Conditions
Rhabdomyosarcoma
Interventions
Procedure: Surgical Resection
Procedure: Proton beam radiation or external beam radiation or brachytherapy
First Posted Date
2023-09-05
Last Posted Date
2025-05-18
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
135
Registration Number
NCT06023641
Locations
🇺🇸

Cook Children's Medical Center, Fort Worth, Texas, United States

🇺🇸

Sanford University, Palo Alto, California, United States

🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

First Posted Date
2023-08-21
Last Posted Date
2025-05-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
105
Registration Number
NCT05999994
Locations
🇺🇸

Childrens Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

Children's Hospital of Colorado, Denver, Colorado, United States

🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

and more 63 locations

DP303c in Patients With HER2-positive Advanced Breast Cancer

Phase 3
Not yet recruiting
Conditions
HER2-positive Advanced Breast Cancer
Interventions
First Posted Date
2023-06-13
Last Posted Date
2023-06-13
Lead Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Target Recruit Count
420
Registration Number
NCT05901935
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