NCT03867123 - A Study to Evaluate the Safety of LAM561 Added to Standard of Care in Newly-diagnosed Glioblastoma Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 4, 2018

Primary Completion Date

July 1, 2020

Study Completion Date

July 1, 2020

Conditions

Glioblastoma (GBM)

Interventions

DRUG

LAM561

Arm 1: Daily for 6 weeks. Arm 2: daily, two 28-day cycles

RADIATION

In Arm 1: Fractionated focal irradiation of 1.8-2 Gy/fraction/day, 5 days/week, 6 weeks. Total dose up to 60 Gy

DRUG

TMZ

Arm 1: 75 mg/m2/day, daily, 6 weeks Arm 2: 200 mg/m2/day, daily the first 5 days of two 28-day cycles (in case of toxicity, TMZ dose may be reduced to 150 mg/m2/day at Cycle 3 to allow for recovery)

Trial Locations (3)

17007

Hospital Universitari de Girona Dr. Josep Trueta, Institut Català d'Oncologia, Girona

08916

Institut Catala d'Oncologia, Hospital Germans Trias I Pujol, Badalona

08908

Hospital Duran i Reynals, Institut Català d'Oncologia, L'Hospitalet de Llobregat