Ignite Creation Date:
2024-05-06 @ 2:11 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01983124
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2013-11-06
Brief Title:
Vemurafenib Fotemustine to Treat Advanced Melanoma Patients With V600BRAF Mutation Recurred While on Vemurafenib
Sponsor:
Paola Queirolo
Organization:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro Genoa Italy
Study Overview
Official Title:
A Phase II Single-arm Study for the Treatment After Recurrence of Advanced Melanoma Patients Harboring the V600BRAF Mutation and Pretreated With Vemurafenib With the Association of Vemurafenib Plus Fotemustine
Status:
COMPLETED
Status Verified Date:
2016-01
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:
BeyPro1
Brief Summary:
The purpose of this study is to evaluate the activity of Vemurafenib in combination with Fotemustine in Patients with unresectable Stage IV melanoma harboring V600 BRAF mutation who recurred while in treatment with Vemurafenib In addition the feasibility and safety profile of prolonging treatment of this drugs combination will be assessed
Detailed Description:
Patients are treated with Fotemustine 100 mgm2 q21 Vemurafenib Vemurafenib will be administered continuous oral dosing at 960 mg twice daily or dose administered at time of disease progression with Vemurafenib previous treatment 720 or 480 mgTreatment will be continued until progression or unacceptable toxicity The Progression-free survival will be assessed as primary endpoint other outcomesie incidence of grade III-IV toxicity Disease Control Rate and Overall Survival will be considered secondary endpoints
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