Therapy Detail

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Therapy Name Vinorelbine
Synonyms
Therapy Description

Navelbine (vinorelbine) is a tubulin binding alkaloid that inhibits tubulin polymerization, thus inhibiting spindle formation, leading to apoptosis (NCI Drug Dictionary). Navelbine (vinorelbine) is approved for use in NSCLC (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Vinorelbine Navelbine Vinorelbin Antimicrotubule Agent 14 Navelbine (vinorelbine) is a tubulin binding alkaloid that inhibits tubulin polymerization, thus inhibiting spindle formation, leading to apoptosis (NCI Drug Dictionary). Navelbine (vinorelbine) is approved for use in NSCLC (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
APC inact mut colon cancer sensitive Vinorelbine Preclinical Actionable In preclinical studies, cells deficient in Apc protein had increased sensitivity to Navelbine (vinorelbine) compared to wild-type cells, and Navelbine (vinorelbine) treament decreased adenoma size in an Apc-deficient mouse model (PMID: 22399804). 22399804

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02492711 Phase III Vinorelbine Capecitabine Gemcitabine Trastuzumab Eribulin Margetuximab-cmkb Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT 9
NCT02000622 Phase III Olaparib Vinorelbine Eribulin Capecitabine Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (OlympiAD) Active, not recruiting USA | ITA | GBR | FRA | ESP 14
NCT03355157 FDA approved Exemestane + Palbociclib Tamoxifen Paclitaxel Exemestane Capecitabine Palbociclib + Tamoxifen Epirubicin Vinorelbine Fulvestrant + Palbociclib Fulvestrant Letrozole Letrozole + Palbociclib A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study). (PADMA) Recruiting DEU 0
NCT01945775 Phase III Gemcitabine Capecitabine Vinorelbine Talazoparib Eribulin A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (EMBRACA) Completed USA | ITA | GBR | FRA | ESP | DEU | BEL | AUS 8
NCT02555657 Phase III Pembrolizumab Eribulin Gemcitabine Vinorelbine Capecitabine Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119) Completed 0
NCT05583188 FDA approved Cisplatin + Nivolumab + Pemetrexed Disodium Cisplatin + Gemcitabine + Nivolumab Carboplatin Cisplatin + Nivolumab + Paclitaxel Carboplatin + Docetaxel + Nivolumab Cisplatin Carboplatin + Gemcitabine + Nivolumab Cisplatin + Docetaxel + Nivolumab Carboplatin + Nivolumab + Paclitaxel Pemetrexed Disodium Vinorelbine Gemcitabine Paclitaxel Carboplatin + Nivolumab + Pemetrexed Disodium Neoadjuvant Aliya PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC (VIGOR) Recruiting USA 0
NCT03901339 Phase III Eribulin Gemcitabine Vinorelbine Capecitabine Sacituzumab govitecan-hziy Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer (TROPiCS-02) Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL 1
NCT02117024 Phase II Cyclophosphamide + HS-110 Pemetrexed Disodium Vinorelbine Erlotinib Gemcitabine Docetaxel Paclitaxel A Phase 2 Study of Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer Terminated USA 0
NCT04697628 Phase III Topotecan Gemcitabine Irinotecan Tisotumab vedotin-tftv Pemetrexed Disodium Vinorelbine Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (innovaTV 301) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT 18
NCT02229149 Phase II Paclitaxel Docetaxel Pertuzumab + Trastuzumab Nab-paclitaxel Vinorelbine Trastuzumab Capecitabine Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer Terminated USA 0
NCT02352948 Phase III Durvalumab Vinorelbine Durvalumab + Tremelimumab Gemcitabine Erlotinib Tremelimumab A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ARCTIC) Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 17
NCT05238831 Phase II Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole SMMART Adaptive Clinical Treatment (ACT) Trial Not yet recruiting USA 0
NCT04943627 Phase III Topotecan Balstilimab Gemcitabine Irinotecan Pemetrexed Disodium Vinorelbine Balstilimab in Patients With Recurrent Cervical Cancer. Withdrawn USA 1
NCT03770299 Phase II Docetaxel Nivolumab Paclitaxel Cisplatin Carboplatin Gemcitabine Pemetrexed Disodium Vinorelbine An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease (CheckMate 9TN) Withdrawn 0
NCT03257267 Phase III Irinotecan Gemcitabine Vinorelbine Pemetrexed Disodium Cemiplimab Topotecan Study of REGN2810 in Adults With Cervical Cancer Completed USA | ITA | GBR | ESP | CAN | BEL | AUS 7
NCT02302807 Phase III Paclitaxel Vinorelbine Atezolizumab Docetaxel A Study of MPDL3280A Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 19
NCT03191786 Phase III Atezolizumab Gemcitabine Vinorelbine A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy (IPSOS) Completed ITA | GBR | ESP | DEU | CAN | BEL 18
NCT05104866 Phase III Gemcitabine Capecitabine Datopotamab deruxtecan Vinorelbine Eribulin A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL 12
NCT02331251 Phase Ib/II Vinorelbine Pembrolizumab Irinotecan Doxorubicin Gemcitabine Docetaxel Nab-paclitaxel Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus) Terminated USA 0
NCT03456076 Phase III Cisplatin Alectinib Carboplatin Gemcitabine Pemetrexed Disodium Vinorelbine A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | AUT | AUS 19
NCT02985658 Phase I Cisplatin Veliparib Vinorelbine Expanded Access With ABT-888 (Veliparib) to Treat Metastatic Breast Cancer No longer available USA 0


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