Glasdegib (PF-04449913) With Temozolomide Newly Diagnosed Glioblastoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

March 15, 2018

Primary Completion Date

November 29, 2023

Study Completion Date

November 29, 2023

Conditions
Glioblastoma
Interventions
DRUG

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."

DRUG

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."

Trial Locations (8)

17007

Institut Catalá de Oncología Girona/Hospital Universitari Dr. Josep Trueta, Girona

28041

Hospital Universitario 12 de Octubre, Madrid

41013

Hospital Universitario Virgen del Rocio, Seville

46009

Hospital Universitario y Politécnico La Fe, Valencia

08916

Institut Catalá de Oncología Badalona/Hospital Germans Trias i Pujol, Badalona

08003

Hospital del Mar, Barcelona

08036

Hospital Clínic i Provincial de Barcelona, Barcelona

Unknown

Hospital Universitario Ramón y Cajal, Madrid

All Listed Sponsors
lead

Grupo Español de Investigación en Neurooncología

OTHER

NCT03466450 - Glasdegib (PF-04449913) With Temozolomide Newly Diagnosed Glioblastoma | Biotech Hunter | Biotech Hunter