Ignite Creation Date:
2024-05-06 @ 7:48 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02608034
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2015-11-03
Brief Title:
A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics PK of Vemurafenib at Steady State
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
A Two-part Phase I Open-label Multicenter Two-period One-sequence Study to Investigate the Effect of Itraconazole and Rifampin on the PK of Vemurafenib at Steady State
Status:
COMPLETED
Status Verified Date:
2020-02
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:
None
Brief Summary:
This is a two-part Phase 1 open-label multicenter two-period one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams mg twice daily BID dosing in adult participants with unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation or other malignant tumor types that harbor a V600-activating mutation of BRAF where the participant has no acceptable standard treatment options
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