Ignite Creation Date:
2024-05-06 @ 1:30 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01826448
Status:
TERMINATED
Last Update Posted:
2020-05-28
First Post:
2013-04-01
Brief Title:
A Phase 1b Open Label Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1b Open Label Dose Escalation Study to Assess Safety Pharmacokinetics Pharmacodynamics and Antitumor Activity of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Unresectable or Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No activity was observed BRAFi-naïve participants should have received triple combination treatment including MEK inhibitor Continuation was not justified
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test the safety of an investigational new drug called PLX3397 when used in combination with Vemurafenib Zelboraf at different dose levels Vemurafenib has been approved by the United States Food and Drug Administration FDAEuropean Medicines Agency EMA for the treatment of a specific category of unresectable or metastatic melanoma
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