Drugs / Navelbine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | NAVELBINE | — | 2001-10-02 – 2002-11-05 | fda.gov ↗ |
| Approved | US (FDA) | NAVELBINE | — | 1994-12-23 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00153907 | Mar 2002 → Sep 2011 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00256815 | Mar 2003 → Sep 2005 | non-small cell lung carcinoma | Clinical Oncology Research Associates | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT01641406 | Mar 2011 → Jan 2013 | ductal breast carcinoma in situ and lobular carcinoma in situ, inflammatory breast carcinoma, invasive lobular breast carcinoma | Auxilio Mutuo Cancer Center | Unknown | No outcome recorded |
| Phase 2 | NCT00632827 | Jul 2008 → Jun 2014 | peripheral T-cell lymphoma, not otherwise specified | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 2 | NCT00830544 | Jul 2008 → Dec 2011 | breast cancer | Auxilio Mutuo Cancer Center | Unknown | No outcome recorded |
| Phase 2 | NCT00198367 | Jan 2003 → Jan 2008 | non-small cell lung carcinoma | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 2 | NCT00148681 | May 2001 → May 2003 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00238849 | — | — | Integrated Community Oncology Network | Unknown | No outcome recorded |
| Phase 2 | NCT00433095 | — | breast carcinoma | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04665986 | Mar 2021 → Feb 2022 | breast cancer | Zhejiang Cancer Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT03359694 | Dec 2017 → Nov 2019 | hereditary neoplastic syndrome | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT00148395 | Jun 2002 → Apr 2008 | non-small cell lung carcinoma | Aktion Bronchialkarzinom e.V. | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT02489409 Background | Oct 2015 → May 2018 | breast cancer | Xinjiang Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT00887783 Background | May 2009 → Sep 2016 | non-small cell lung carcinoma | Odense University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00148668 Comparator | Dec 2003 → Jan 2009 | breast cancer | Eric Winer, MD | Completed | No outcome recorded |
| Phase 3 | NCT03203590 Comparator | Sep 2017 → Jan 2026 | — | Sun Yat-sen University | Unknown | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Navelbine | “Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.” NCT00238849 ↗15“Navelbine 25 mg/M2 in 250 cc NS over 60 min on day 1 and day 8” NCT00830544 ↗ “The drug Navelbine is part of this class of drugs.” NCT00256815 ↗ “Navelbine IVD 25 mg/m2 D1、D8” NCT03359694 ↗ |
| Known as | NVB | “NVB” NCT02489409 ↗ |
| Route | Oral | “Patients will be given oral navelbine on days 1 and 8 of each cycle” NCT00153907 ↗ |