Ignite Creation Date:
2024-05-06 @ 1:49 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01909453
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2013-07-24
Brief Title:
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A 2-part Phase III Randomized Open Label Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COLUMBUS
Brief Summary:
This is 2-part randomized open label multi-center parallel group phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation A total of approximately 900 patients will be randomized
Part 1
Patients will be randomized in a 111 ratio to one of 3 treatment arms
1 LGX818 450 mg QD plus MEK162 45 mg BID denoted as Combo 450 arm
2 LGX818 300 mg QD monotherapy denoted as LGX818 arm or
3 vemurafenib 960 mg BID denoted as vemurafenib arm
Part 2
Patients will be randomized in a 31 ratio to one of the 2 treatment arms
1 LGX818 300 mg QD plus MEK162 45 mg BID denoted as Combo 300 arm or
2 LGX818 300 mg QD monotherapy denoted as LGX818 arm
Part 1
Patients will be randomized in a 111 ratio to one of 3 treatment arms
1 LGX818 450 mg QD plus MEK162 45 mg BID denoted as Combo 450 arm
2 LGX818 300 mg QD monotherapy denoted as LGX818 arm or
3 vemurafenib 960 mg BID denoted as vemurafenib arm
Part 2
Patients will be randomized in a 31 ratio to one of the 2 treatment arms
1 LGX818 300 mg QD plus MEK162 45 mg BID denoted as Combo 300 arm or
2 LGX818 300 mg QD monotherapy denoted as LGX818 arm
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C4221004 | OTHER | None | None |
| 2013-001176-38 | EUDRACT_NUMBER | Alias Study Number | None |