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 |
|---|---|---|---|---|---|---|
| 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | 0 |
| 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 |
| 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) | Completed | 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 | POL | ITA | ISR | IRL | GBR | FRA | ESP | DEU | BRA | BEL | AUS | 4 |
| NCT04943627 | Phase III | Topotecan Balstilimab Gemcitabine Irinotecan Pemetrexed Disodium Vinorelbine | Balstilimab in Patients With Recurrent Cervical Cancer. | Withdrawn | USA | 1 |
| 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 | TUR | ROU | POL | ITA | HUN | GBR | FRA | ESP | CZE | CHE | BGR | 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 | TUR | SWE | SVN | ROU | POL | NOR | NLD | ITA | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 6 |
| 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 | ROU | POL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BGR | BEL | AUS | 9 |
| NCT06908993 | Phase III | Vinorelbine Pemetrexed Disodium Tepotinib Pembrolizumab Bevacizumab + Paclitaxel Paclitaxel Docetaxel Nivolumab Atezolizumab Gemcitabine | Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated (COMET) | Not yet recruiting | FRA | 0 |
| 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 |
| 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 | Withdrawn | 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 | TUR | ROU | POL | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DNK | DEU | AUT | AUS | 12 |
| 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 | |
| NCT02985658 | Phase I | Cisplatin Veliparib Vinorelbine | Expanded Access With ABT-888 (Veliparib) to Treat Metastatic Breast Cancer | No longer available | USA | 0 |
| 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 |
| 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 | POL | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | ARG | 7 |
| 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) | Terminated | USA | 0 |
| NCT06377566 | Phase II | Brentuximab vedotin + Dacarbazine + Doxorubicin + Vinblastine Gemcitabine Dacarbazine Doxorubicin Pembrolizumab Brentuximab vedotin Vinorelbine Vinblastine | A Study of BV-AVD in People With Bulky Hodgkin Lymphoma | Recruiting | USA | 0 |
| 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 | |
| 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 | POL | NLD | ITA | ISR | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | AUT | 3 |
| 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 | SVK | ROU | POL | LUX | ITA | IRL | GBR | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BGR | BEL | ARG | 7 |
| NCT04697628 | Phase III | Topotecan Gemcitabine Irinotecan Tisotumab vedotin-tftv Pemetrexed Disodium Vinorelbine | Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (innovaTV 301) | Active, not recruiting | USA | SWE | POL | NOR | NLD | ITA | IRL | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | ARG | 7 |
| NCT03257267 | Phase III | Irinotecan Gemcitabine Vinorelbine Pemetrexed Disodium Cemiplimab Topotecan | Study of REGN2810 in Adults With Cervical Cancer | Completed | USA | POL | ITA | GRC | GBR | ESP | CAN | BRA | BEL | AUS | 4 |
| NCT06564844 | Phase III | Tegafur-gimeracil-oteracil Potassium Etoposide AZD2936 + Datopotamab deruxtecan Carboplatin AZD2936 Vinorelbine Pemetrexed Disodium Cisplatin | A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12) | Recruiting | USA | TUR | SWE | POL | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BEL | 7 |
| NCT06459180 | Phase III | Gemcitabine Irinotecan Tisotumab vedotin-tftv Pemetrexed Disodium Vinorelbine Topotecan SKB264 | A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) | Recruiting | USA | SWE | POL | NOR | NLD | ITA | ISR | IRL | GRC | GBR | FRA | FIN | ESP | DNK | CHE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 8 |
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