29
Participants
Start Date
October 15, 2019
Primary Completion Date
January 3, 2023
Study Completion Date
January 3, 2023
Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 1)
"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.~• Level -1 = Hydroxychloroquine 400 mg by mouth once a day"
Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 2)
"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.~• Level 1 (starting dose) = Hydroxychloroquine 800 mg by mouth once a day"
Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 3)
"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.~• Level 2 = Hydroxychloroquine 600 mg by mouth two times a day"
INSTITUT Claudius Rigaud, Toulouse
CHU Grenoble Alpes, La Tronche
CHU Estaing, Clermont-Ferrand
Centre Hospitalier Lyon Sud, Lyon
AP-HP_HOPITAL Saint Louis, Paris
Hospices Civils de Lyon
OTHER