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Navelbine

(Vinorelbine Tartrate)

Phase 3Small molecule

GGynecologic Oncology Group

Vinorelbine tartrate is a chemotherapy drug used to treat certain types of cancer, particularly lung cancer and breast cancer, by stopping cancer cells from dividing and growing.[1] Navelbine is currently being investigated across 16 indications[3], with its most advanced program in Phase 3.[1]

Navelbine is one of 473 small molecule programs targeting Kidney Cancer. It is currently in Phase 3.

16

Indications

80

Total Trials

9

Active Trials

472

Competitors

Pipeline

Status by Indication[3][1]

Indication

Kidney CancerActive, not recruiting

Lung CancerActive, not recruiting

LymphomaActive, not recruiting

Malignant Pleural MesotheliomaActive, not recruiting

Hodgkins LymphomaActive, not recruiting

Malignant Colon NeoplasmActive, not recruiting

Malignant MesotheliomaActive, not recruiting

Breast NeoplasmActive, not recruiting

Metastatic Prostate CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Kidney CancerPhase 2

Active, not recruiting

Lung CancerPhase 3

Active, not recruiting

LymphomaPhase 3

Active, not recruiting

Malignant Pleural MesotheliomaPhase 3

Active, not recruiting

Hodgkins LymphomaPhase 2

Active, not recruiting

Malignant Colon NeoplasmPhase 2

Active, not recruiting

Malignant MesotheliomaPhase 2

Active, not recruiting

Breast NeoplasmPhase 3

Active, not recruiting

Metastatic Prostate CancerPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Navelbine

GGynecologic Oncology Group

Avastin

BBio-Thera Solutions

DATROWAY

Cymbalta

Alnylam Pharmaceuticals

Voltaren

Zolymbus

Blenoxane

Bristol-Myers Squibb

MS Contin

HHikma Pharmaceuticals LLC

Acupan

YYonsei University

Feraheme

AAzurity Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 1/2Recruiting

Breast Cancer

NCT06202261

Q3 2028

Phase 3Not yet recruiting

Breast Cancer

NCT05901935

Active, not recruiting

Advanced Breast Cancer

NCT06500494

Q1 2029

Phase 3Recruiting

Breast Cancer

NCT06079983

Q2 2029

Phase 3Recruiting

Non-Small Cell Lung Cancer

NCT05487391

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer24 trials

Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00005838·756 enrolled

Vinorelbine Tartrate and Paclitaxel in Treating Older Patients With Advanced Non-Small Cell Lung Cancer

Completed·UUniversity of Nebraska·Phase 2·NCT00602797·20 enrolled

S0027: Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

Completed·SSWOG Cancer Research Network·Phase 2·NCT00026156·125 enrolled

Show 21 more trials

Vinorelbine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00008333·59 enrolled

Hydroxyurea Plus Combination Chemotherapy in Patients With Non-small Cell Lung Cancer

Unknown status·OOttawa Regional Cancer Centre·Phase 1·NCT00002887·30 enrolled

Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Unknown status·IIstituto Nazionale per lo Studio e la Cura dei Tumori·Phase 3·NCT00004100

Radiation Therapy With or Without Vinorelbine and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Completed·MMedical Research Council·Phase 2/3·NCT00253591·500 enrolled

Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Unknown status·—·Phase 2·NCT00005825

Surgery With or Without Preoperative Chemotherapy in Treating Patients With Resectable Non-small Cell Lung Cancer

Completed·MMedical Research Council·Phase 3·NCT00003159·600 enrolled

Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

Terminated·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00863512·34 enrolled

A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.

Recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT05487391·632 enrolled

Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Terminated·CCTI BioPharma·Phase 3·NCT00054197

First-Line Chemotherapy With or Without Neuromuscular Electrical Stimulation in Treating Patients With Non-Small Cell Lung Cancer

Unknown status·WWales Cancer Trials Unit·Phase 2·NCT01097317·52 enrolled

Vinorelbine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Completed· GSK logo

GSK·Phase 2·NCT00005865

Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 3·NCT00002823·3,300 enrolled

Vinorelbine and Bevacizumab in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Completed·UUniversity of Rochester·Phase 2·NCT00309998·50 enrolled

Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

Unknown status·—·Phase 2·NCT00083083·250 enrolled

First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Unknown status·YYonsei University·Phase 2·NCT00736814·117 enrolled

Cisplatin Plus Vinorelbine With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Completed· Sanofi logo

Sanofi·Phase 3·NCT00017459

Vinorelbine and/or Gemcitabine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Unknown status·IIstituto Nazionale per lo Studio e la Cura dei Tumori·Phase 3·NCT00003447·630 enrolled

Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

Unknown status·NNational Cancer Institute (NCI)·Phase 3·NCT00003240·1,800 enrolled

Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer

Completed·JJapan Multinational Trial Organization·Phase 3·NCT00079287

Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01443078·42 enrolled

Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Unknown status· Amgen logo

Amgen·Phase 2·NCT00006215

Breast Cancer22 trials

DP303c in Patients With HER2-positive Advanced Breast Cancer

Not yet recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 3·NCT05901935·420 enrolled

Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

Completed·UUniversity of Washington·Phase 2·NCT00194779·50 enrolled

Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00093808·47 enrolled

Show 19 more trials

Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00017394·56 enrolled

Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer

Completed·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT00004237

A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain

Terminated·—·Phase 2·NCT00476827·16 enrolled

Breast Cancer Treatment Based on Organ-like Culture

Unknown status·XXijing Hospital··NCT03925233·300 enrolled

Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·N/A·NCT00003730·80 enrolled

Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement

Completed·SSwiss Cancer Institute·Phase 1/2·NCT00003902·110 enrolled

Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

Terminated·UUniversity of Washington·Phase 2·NCT00194792·28 enrolled

Veliparib, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer

Completed·UUniversity of Washington·Phase 1·NCT01104259·50 enrolled

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

Recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 1/2·NCT06202261·154 enrolled

Vinorelbine in Treating Older Women With Stage IV Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00022152·25 enrolled

Vinorelbine With or Without Trastuzumab in Treating Women With Progressive Metastatic Breast Cancer

Completed·SSWOG Cancer Research Network·Phase 3·NCT00103233

Capecitabine Compared With Vinorelbine in Treating Women With Metastatic Breast Cancer

Terminated·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2/3·NCT00049660·47 enrolled

the Role of Two Different Metronomic Chemotherapy Regimens in Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (TNBC) as Maintenance Therapy After First Line Treatment

Terminated· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT03358004·4 enrolled

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

Recruiting·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 3·NCT06079983·400 enrolled

Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 3·NCT06255392·200 enrolled

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

Recruiting·SShanghai Yizhong Pharmaceutical Co., Ltd.·Phase 3·NCT06143553·168 enrolled

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

Unknown status·RRemeGen Co., Ltd.·Phase 3·NCT04400695·366 enrolled

Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of HER2-positive Metastatic Breast Cancer

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT05823623·30 enrolled

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

Unknown status·ZZhiyong Yu·Phase 2·NCT03703427·200 enrolled

Lymphoma9 trials

Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma

Completed·CChildren's Oncology Group·Phase 2·NCT00006760·66 enrolled

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

Completed·AAlliance for Clinical Trials in Oncology·Phase 1/2·NCT00006029·91 enrolled

Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

Completed·CChildren's Oncology Group·Phase 3·NCT01026220·166 enrolled

Show 6 more trials

Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma

Completed·CChildren's Oncology Group·Phase 2·NCT00070304·33 enrolled

Bortezomib, Ifosfamide, and Vinorelbine Tartrate in Treating Young Patients With Hodgkin's Lymphoma That is Recurrent or Did Not Respond to Previous Therapy

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00381940·26 enrolled

Three Different Therapy Regimens in Treating Patients With Previously Untreated Hodgkin Lymphoma

Terminated·FFrench Innovative Leukemia Organisation·Phase 3·NCT00920153·442 enrolled

Combination Chemotherapy Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or High-Risk Primary Refractory Hodgkin Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00574496·25 enrolled

SGN-30 and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00337194·30 enrolled

Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma

Completed·CChildren's Oncology Group·Phase 3·NCT00302003·287 enrolled

Metastatic Prostate Cancer5 trials

Vinorelbine in Treating Patients With Metastatic Prostate Cancer

Completed·SSwiss Cancer Institute·Phase 2·NCT00003259·40 enrolled

Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Unknown status·GGERCOR - Multidisciplinary Oncology Cooperative Group·Phase 2·NCT00006114

Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy

Withdrawn·JJames Ahlgren·Phase 2·NCT00003622

Show 2 more trials

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT00003400·45 enrolled

Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy

Completed·GGroupe D'Etude des Tumeurs Uro-Genitales·Phase 2·NCT00627354·90 enrolled

Rhabdomyosarcoma4 trials

A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)

Not yet recruiting·CChildren's Oncology Group·Phase 3·NCT07466316·342 enrolled

A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma

Active, not recruiting·CChildren's Oncology Group·Phase 3·NCT04994132·118 enrolled

Combination Chemotherapy in Treating Young Patients With Nonmetastatic Rhabdomyosarcoma

Unknown status·EEuropean Paediatric Soft Tissue Sarcoma Study Group·Phase 3·NCT00379457·600 enrolled

Show 1 more trial

Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01222715·87 enrolled

16 more indications

Malignant Mesothelioma1 trial

Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma

Unknown status·BBritish Thoracic Society·Phase 2·NCT00030459

Brain Metastases1 trial

Temozolomide and Vinorelbine in Treating Patients With Recurrent Brain Metastases

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT00026494·49 enrolled

Advanced Solid Tumors1 trial

Vinorelbine in Treating Patients With Metastatic or Advanced Solid Tumors

Unknown status·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT00006088

Chemotherapy1 trial

Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

Completed·GGynecologic Oncology Group·Phase 3·NCT00064077·513 enrolled

Acute Leukemia1 trial

Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00462787·23 enrolled

Colon Cancer1 trial

Vinorelbine in Advanced BRAF-like Colon Cancer

Completed·TThe Netherlands Cancer Institute·Phase 2·NCT03482362·1 enrolled

Kidney Cancer1 trial

Combination Chemotherapy With or Without Prednisone in Treating Patients With Recurrent and/or Metastatic Kidney Cancer

Completed·UUniversity of New Mexico·Phase 2·NCT00003584·35 enrolled

Radiation Therapy1 trial

Vinorelbine and Paclitaxel Plus Radiation Therapy in Treating Patients With Advanced Cancer Arising in the Pelvis

Completed·UUniversity of Chicago·Phase 1·NCT00002949·33 enrolled

Hematologic Malignancies1 trial

Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies

Unknown status·MMetronome Therapeutics·Phase 1·NCT00641160·12 enrolled

Recurrent or Refractory1 trial

Vinorelbine in Treating Children With Recurrent or Refractory Cancers

Completed·CChildren's Oncology Group·Phase 2·NCT00003234·50 enrolled

Lung Cancer1 trial

Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

Completed·MMedical University of South Carolina·Phase 1·NCT00287963·18 enrolled

Cervical Cancer1 trial

Combination Chemotherapy in Treating Patients With Recurrent or Refractory Cervical Cancer

Completed·GGynecologic Oncology Group·Phase 2·NCT00002813·62 enrolled

Advanced Cancer1 trial

A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.

Completed·MMast Therapeutics, Inc.·Phase 1·NCT00432562·31 enrolled

Malignant Pleural Mesothelioma1 trial

Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma

Completed·MMedical Research Council·Phase 3·NCT00075699·840 enrolled

Advanced Breast Cancer1 trial

Advanced Breast Cancer Patients Treated With Oral Vinorelbine: a Prospective and Retrospective, Observational Study - VINOREAL

Active, not recruiting·PPierre Fabre Medicament··NCT06500494·368 enrolled

Lung Non-Small Cell Carcinoma1 trial

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC)

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00324805·1,501 enrolled

Sources

References

[1]
ClinicalTrials.gov — 80 trial records for Vinorelbine Tartrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Vinorelbine Tartrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Vinorelbine Tartrate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Gynecologic Oncology Group company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tubulin Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GGynecologic Oncology Group

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