75
Participants
Start Date
March 15, 2018
Primary Completion Date
November 29, 2023
Study Completion Date
November 29, 2023
PF-04449913
"Glasdegib (3 dose levels will be evaluated: 100mg QD, 150mg QD and 200mg QD, or 75-50mg) will be administered:~During concurrent phase concomitantly with radiation and Extended to the resting period (glasdegib will not be stopped in the 4 weeks of radiotherapy resting period).~During adjuvant therapy with Temozolomide Oral Capsule. Additional treatment with glasdegib beyond 6 sequential TMZ cycles will continue until progression, unacceptable toxicity, non-compliance, consent withdrawal and/or 2 years of glasdegib administration."
Temozolomide Oral Capsule
"During RT, patients will receive Temozolamide (TMZ). All patients will be given TMZ at 75 mg/m2~/d concurrently with RT for a maximum of 42 days. At 4 weeks after RT completion, patients will start taking TMZ at 150 mg/m2/d for the first 5 days of a 28-day cycle. If first cycle is well tolerated, patients will receive TMZ at 200 mg/m2/d for the first 5 days of every subsequent 28-day cycle for another 5 cycles."
Institut Catalá de Oncología Girona/Hospital Universitari Dr. Josep Trueta, Girona
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario Virgen del Rocio, Seville
Hospital Universitario y Politécnico La Fe, Valencia
Institut Catalá de Oncología Badalona/Hospital Germans Trias i Pujol, Badalona
Hospital del Mar, Barcelona
Hospital Clínic i Provincial de Barcelona, Barcelona
Hospital Universitario Ramón y Cajal, Madrid
Grupo Español de Investigación en Neurooncología
OTHER