Vemurafenib + Fotemustine to Treat Advanced Melanoma Patients With V600BRAF Mutation Recurred While on Vemurafenib (BeyPro1)
|ClinicalTrials.gov Identifier: NCT01983124|
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma Stage IV||Drug: Fotemustine + Vemurafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||February 2013|
|Primary Completion Date :||April 2014|
|Study Completion Date :||September 2015|
Experimental: Fotemustine + Vemurafenib
Fotemustine 100 mg/m2 q21 + Vemurafenib gelatin capsules supplied as 240-mg strengths. Vemurafenib will be administered continuous oral dosing at 960 mg twice daily or dose administered at time of disease progression with Vemurafenib previous treatment.
Drug: Fotemustine + Vemurafenib
Fotemustine 100mg/m2 IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity.
Vemurafenib administered continuous oral dosing 960 mg twice daily or dose administered at time of progression since progression or unacceptable toxicity.
- Progression-free survival [ Time Frame: 6 months ]To assess activity of vemurafenib in combination with fotemustine, in patients harboring the V600BRAF mutation and recurred while on treatment with Vemurafenib.
- Incidence of Grade 3-4 toxicities (any type) [ Time Frame: 6 months ]
- Rate, duration of response and proportion of patients with duration of response lasting > 24 weeks [ Time Frame: 6 months ]
- Disease control rate; [ Time Frame: 6 months ]
- Time to progression of brain metastases (BM), Including incidence of BM in pts free from BM at the time of enrolment [ Time Frame: 6 months ]
- Overall survival (OS). [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983124
|Genova, Italy, 16132|
|Istituto Nazionale per lo Studio e la Cura dei Tumori "G.Pascale"|
|Napoli, Italy, 80131|
|Principal Investigator:||Paola Queirolo, MD||IRCCS AOU San Martino IST|