Drugs / Vinflunine
Vinflunine
also known as
BMS-710485 · F-12158 · Javlor · Vinflunina · Vinflunine bitartrate · VINFLUNINE DITARTRATE · Vinflunine is marketed as Javlor. · Vinflunine tartrate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Javlor | — | 2009-09-21 | europa.eu ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT01844947 | May 2012 → Oct 2017 | renal pelvis carcinoma, ureter cancer, urethra cancer, urinary bladder cancer +1 | Dr Anders Ullén | Completed | No outcome recorded |
| Phase 1 | NCT00534807 | Sep 2007 → Nov 2008 | cancer | Bristol-Myers Squibb | Withdrawn | No outcome recorded |
| Phase 1 | NCT00320073 | Aug 2006 → Oct 2008 | cancer of unknown primary site | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00362830 | Aug 2006 → Sep 2007 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00388557 | Oct 2005 → Sep 2007 | cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02845050 | Jul 2016 → Jul 2017 | urinary bladder cancer | Ligartis GmbH | Withdrawn | No outcome recorded |
| Phase 210 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT02665039 | Apr 2014 → Sep 2018 | renal pelvis carcinoma, ureter cancer, urethra cancer, urinary bladder cancer +1 | Dr Anders Ullén | Completed | Missed primary |
| Phase 2 | NCT02057913 | Mar 2014 → Nov 2018 | penile neoplasm | Institute of Cancer Research, United Kingdom | Completed | Met primary |
| Phase 2 | NCT01529411 | Feb 2012 → Feb 2013 | transitional cell carcinoma | Spanish Oncology Genito-Urinary Group | Completed | Met primary |
| Phase 2 | NCT00519831 | Aug 2007 → Feb 2008 | lung cancer | UNC Lineberger Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00545766 | May 2007 → Jan 2008 | prostate cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00450515 | Mar 2007 → Jan 2009 | breast cancer | Alliance for Clinical Trials in Oncology | Withdrawn | No outcome recorded |
| Phase 2 | NCT00284154 | Jan 2006 → May 2009 | lung cancer, small cell carcinoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00284180 | Jan 2006 → Feb 2008 | breast cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00251446 | Oct 2005 → Mar 2008 | non-small cell lung carcinoma | Veeda Oncology | Completed | No outcome recorded |
| Phase 2 | NCT00101608 | Jan 2005 → Apr 2007 | kidney neoplasm, transitional cell carcinoma, ureter neoplasm, urinary bladder cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00359476 | Mar → Oct 2007 | gastric cancer | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2/3 | NCT00389155 | Jan 2007 → Jan 2008 | metastatic carcinoma, transitional cell carcinoma, urinary bladder cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 37 trials · 1 met primary · 3 missed | ||||||
| Phase 3 | NCT03390504 | Mar 2018 → Apr 2024 overdue | urothelial carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02347332 | Apr 2014 → Oct 2017 | head and neck carcinoma | Pierre Fabre Laboratories | Completed | Missed primary |
| Phase 3 | NCT01953003 | Sep 2013 → Jul 2017 | breast cancer | Pierre Fabre Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT01091168 | Jul 2009 → Aug 2012 | breast cancer, metastatic neoplasm | Pierre Fabre Laboratories | Completed | Missed primary |
| Phase 3 | NCT01095003 | May 2009 → Dec 2011 | breast cancer | Pierre Fabre Laboratories | Completed | Met primary |
| Phase 3 | NCT02054338 | Jun 2006 → Jun 2011 | female breast carcinoma | Pierre Fabre Laboratories | Terminated | Missed primary |
| Phase 3 | NCT00315237 | Jul 2005 → Jan 2008 | transitional cell carcinoma, urinary bladder cancer | Pierre Fabre Laboratories | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1/2 | NCT01265940 Background | Mar 2011 → Jan 2012 | urothelial carcinoma | Prof. Dr. Thomas Otto | Completed | No outcome recorded |
| Phase 2 | NCT01599013 Background | Feb 2011 → Oct 2013 | bladder transitional cell carcinoma | Pierre Fabre Laboratories | Completed | No outcome recorded |
| Phase 2/3 | NCT03410693 Comparator | May 2018 → Oct 2020 | transitional cell carcinoma | Bayer | Completed | Missed primary |
| Phase 2/3 | NCT01830231 Comparator | Oct 2012 → Nov 2016 | urothelial carcinoma | Associació per a la Recerca Oncologica, Spain | Unknown | Missed primary |
| Phase 3 | NCT07419295 Comparator | Apr 2026 → Jul 2029 expected | urinary bladder cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT04527991 Comparator | Jan 2021 → Jul 2025 | urothelial carcinoma | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT03474107 Comparator | Jun 2018 → Jul 2020 | ureter cancer, urinary bladder cancer, urothelial carcinoma | Astellas Pharma Global Development, Inc. | Completed | Met primary |
| Phase 3 | NCT02302807 Comparator | Jan 2015 → Mar 2017 | urinary bladder cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT02256436 Comparator | Oct 2014 → Sep 2016 | urothelial carcinoma | Merck Sharp & Dohme LLC | Completed | Mixed |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vinflunine | “Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle)” NCT03410693 ↗ |
| Known as | BMS-710485 | “The purpose of this study is to test an investigational drug, vinflunine (BMS-710485), in combination with gemcitabine in patients with Transitional Cell Carcinoma who cannot...” NCT00389155 ↗ |
| Known as | F-12158 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110725 ↗ |
| Known as | Javlor | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110725 ↗ |
| Known as | Vinflunina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110725 ↗ |
| Known as | Vinflunine bitartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110725 ↗ |
| Known as | VINFLUNINE DITARTRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110725 ↗ |
| Known as | Vinflunine is marketed as Javlor. | “Vinflunine is marketed as Javlor.” NCT01265940 ↗ |
| Known as | Vinflunine tartrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2110725 ↗ |
| Action | Inhibit | “Vinflunine is a new microtubule inhibitor with preclinical activity in small cell lung cancer (SCLC).” PMID 20521355 ↗ Jun 2010 |
| Modality | Small molecule | “Novel second generation vinca alkaloid” NCT00284180 ↗ |
| Route | Intravenous | “Intravenous (IV) Vinflunine” NCT00101608 ↗ |