Drugs / lapatinib ditosylate
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | TYKERB | — | 2010-01-29 – 2018-12-06 | fda.gov ↗ |
| Approved | US (FDA) | TYKERB | — | 2007-03-13 | fda.gov ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00379509 | Apr 2006 → Jun 2010 | breast cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00498953 | May 2007 → Nov 2008 | head and neck cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT01688609 | Jul 2012 → Dec 2013 | HER2 positive breast carcinoma, female breast carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00684983 | Jul 2008 → Jan 2014 | HER2 positive breast carcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT01104571 | Apr 2010 → Aug 2017 | female breast carcinoma | Institute of Cancer Research, United Kingdom | Unknown | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | lapatinib ditosylate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01104571 ↗ |
| Known as | lapatinib | “lapatinib ditosylate (lapatinib)” NCT00684983 ↗ |
| Action | Inhibit | “Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.” NCT00379509 ↗ |
| Modality | Small molecule | “lapatinib, a dual EGFR/ErbB2 kinase inhibitor” NCT00498953 ↗ |
| Route | Oral | “Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity.” NCT00379509 ↗ |
| Target | EGFR | “dual EGFR/ErbB2 kinase inhibitor” NCT00498953 ↗ |
| Target | ERBB2 | “dual EGFR/ErbB2 kinase inhibitor” NCT00498953 ↗ |