NCT04250922 - LAM561 With RT and TMZ for Adults With Glioblastoma | Biotech Hunter

Enrollment

140

Participants

Timeline

Start Date

December 1, 2019

Primary Completion Date

October 15, 2024

Study Completion Date

May 30, 2025

Conditions

Primary GlioblastomaGlioblastoma Multiforme

Interventions

DRUG

LAM561

"Subjects in Arm B will receive orally LAM561 during the Chemoradiation Phase.~Subjects in Arm B will receive LAM561 orally during the Maintenance (Adjuvant) Phase. Patients will continue to be administered with LAM561/Placebo after cycle 6 of the monotherapy phase until end of study. Adjuvant treatment will be discontinued upon determination of tumour progression as defined by RANO criteria, unacceptable toxicity, or refusal to continue study treatment."

DRUG

TMZ

"TMZ will be administered at 75 mg/m2, orally, once daily, continuously from Day 1 of radiotherapy to the last day of radiation for a maximum of 49 days.~During the Maintenance (Adjuvant) Phase, all subjects will receive oral TMZ 150 - 200 mg/m2 once daily on Days 1 - 5 of each 28-day cycle for 6 cycles."

RADIATION

During the Chemoradiation Phase, all subjects will undergo focal RT, with one treatment given daily 5 days per week over approximately 6 weeks (and no more than 7 weeks).

Trial Locations (22)

35131

Istituto Oncologico Veneto IRCCS, Padua

46026

Hospital Universitari i Politécnic La Fe., Valencia

Unknown

Institut Cancerologie de L'Ouest (ICO), Angers

Centre Eugène Marquis (CEM), Rennes

Gustave Roussy University Hospital, Rennes

Institut universitaire du cancer, Toulouse

Reaserch Fund of the Hadassah Medical Organization, Jerusalem

Istituto Nazionale Neurologico Carlo Besta, Milan

"Istituto Nazionale Tumori Regina Elena", Roma

University of Turin, Turin

Hospital Universitario Reina Sofía, Córdoba

Hospital Universitario Virgen del Rocío, Seville

Hospital Clinic, Barcelona

Hospital del Mar, Barcelona

Hospital Vall d'Hebron, Barcelona

Hospital Clínico San Carlos, Madrid

Hospital Universitario 12 De Octubre, Madrid

Hospital Parc Tauli, Sabadell

University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital, Birmingham

Cambridge university hospital, Cambridge

The Royal Marsden Hospital, London

NE7 7DN

Freeman Hospital's Northern Centre of Cancer Care, Newcastle