Vemurafenib + Fotemustine to Treat Advanced Melanoma Patients With V600BRAF Mutation Recurred While on Vemurafenib (BeyPro1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||April 2014|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|