LGX818
PFIZER INC PFE · Melanoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- PFIZER INC PFE Source: Company record for PFIZER INC (opens in a new tab)
- Indication
- Melanoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 12 Sep 20131 linked trial
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for LGX818. Editors add each one with its source.
Filed application
No filed application is on record for LGX818. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for LGX818.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT01909453ClinicalTrials.gov record for NCT01909453 (opens in a new tab)COLUMBUS | Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma | Phase 3 | Completed | 921 (actual) | 9 Nov 2016 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT01909453 (opens in a new tab) |
Posted results on ClinicalTrials.gov for COLUMBUS Serious adverse events (Baseline up to 30 days from last dose of study drug (P1: up to 117.8 M for LGX818+MEK162 [combo 450]; up to 111.4 M for LGX818 300mg; up to 110.5 M for Vemurafenib 960mg; P2: up to 106.3 M for LGX818+MEK162 45mg [combo 300]; up to 98.4 M for LGX818 300mg)): Part 2: LGX818 300 mg QD +MEK162 45 mg BID (Combo 300) 98 of 257; Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) 84 of 192; Part 1: LGX818 300 mg 71 of 192; Part 2: LGX818 300 mg 31 of 84; Part 1: Vemurafenib 960 mg BID 78 of 186 Source: ClinicalTrials.gov results for NCT01909453 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing COLUMBUS (9), newest first
All 9 publications for NCT01909453 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as LGX818.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT01909453 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.