Vinorelbine

Generic Name: Vinorelbine

Drug Type: Small Molecule

Chemical Formula: C_₄₅H_₅₄N_₄O_₈

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

Clinical Trials

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

Phase 1

Recruiting

Conditions: Rhabdomyosarcoma

Interventions: Radiation: radiotherapy
Drug: Irinotecan
Drug: Vinorelbine
Drug: Actinomycin D
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Ifosfamide
Drug: Temozolomide
Drug: Regorafenib
Drug: Vincristine

First Posted Date: 2020-11-12

Last Posted Date: 2024-05-23

Lead Sponsor: University of Birmingham

Target Recruit Count: 1672

Registration Number: NCT04625907

Locations: 🇬🇷
University Unit of Pediatric Oncology-hematology - Children's Hospital Agia Sophia, Athens, Greece
🇮🇱
Rambam Health Care Campus, Haifa, Israel
🇮🇱
Hadassah University Medical Centre, Jerusalem, Israel

and more 125 locations

PD-1 Inhibitor or PD-1 Inhibitor Plus GVD for Relapsed/Refractory CHL

Phase 2

Recruiting

Conditions: Refractory or Relapsed Classical Hodgkin Lymphoma
Classical Hodgkin Lymphoma

Interventions: Drug: PD-1 inhibitor
Drug: PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome

First Posted Date: 2020-11-12

Last Posted Date: 2022-05-09

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 42

Registration Number: NCT04624984

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
🇨🇳
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,, Guangzhou, Guangdong, China
🇨🇳
The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, Guangdong, China

A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Phase 3

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Paclitaxel Injection
Drug: RC48-ADC
Drug: Docetaxel Injection
Drug: Vinorelbine Tartrate Injection
Drug: Capecitabine Tablets

First Posted Date: 2020-05-22

Last Posted Date: 2024-01-24

Lead Sponsor: RemeGen Co., Ltd.

Target Recruit Count: 366

Registration Number: NCT04400695

Locations: 🇨🇳
Oncology Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

Safety and Efficacy of Toripalimab in HER2- Metastatic Breast Cancer Patients Treated With Metronomic Vinorelbine

Phase 2

Conditions: Metastatic Breast Cancer

Interventions: Drug: Vinorelbine 40mg
Biological: Toripalimab 240mg
Drug: Cyclophosphamide 50 mg
Biological: Bevacizumab 5 mg/kg
Drug: Cisplatin
Drug: Capecitabine 500Mg Oral Tablet

First Posted Date: 2020-05-15

Last Posted Date: 2022-02-25

Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Target Recruit Count: 138

Registration Number: NCT04389073

Locations: 🇨🇳
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China
🇨🇳
Beijing Huanxing Cancer Hospital, Beijing, Beijing, China

Evolutionary Therapy for Rhabdomyosarcoma

Phase 2

Recruiting

Conditions: Rhabdomyosarcoma

Interventions: Drug: Vincristine
Drug: Cyclophosphamide
Drug: Vinorelbine
Drug: Actinomycin D
Drug: Cyclophosphamide Pill

First Posted Date: 2020-05-14

Last Posted Date: 2025-03-17

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 28

Registration Number: NCT04388839

Locations: 🇺🇸
Connecticut Children's Medical Center, Hartford, Connecticut, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
Primary Children's Medical Center/Utah, Salt Lake City, Utah, United States

and more 15 locations