Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

July 31, 2031

Study Completion Date

July 31, 2031

Conditions
GlioblastomaBrain CancerGlioblastoma MultiformeGlioblastoma Multiforme of BrainGlioblastoma Multiforme, AdultMGMT-Unmethylated GlioblastomaMGMT-Methylated Glioblastoma
Interventions
DRUG

Ruxolitinib

"During Radiation Therapy phase: 20 mg ruxolitinib will be self-administered orally (PO) twice every day (BID), starting on Day 1 for 6 weeks. Then there will be a 4-week break after radiotherapy is complete.~Maintenance phase: Occurs thirty days (4 weeks) after receiving the last dose of radiotherapy. Ruxolitinib 20 mg will be self-administered PO BID, starting on Day 1 in consecutive 28-day cycles.~Either phase:~Aside from the 30-day break, ruxolitinib will be continued daily until disease progression or treatment intolerance. Ruxolitinib should be administered at approximately the same time each day. The tablets should be swallowed whole with water and should not be opened, broken, or chewed. The dose may be reduced in the case of certain adverse events."

DRUG

Temozolomide

"During Radiation Therapy phase: 75 mg/m\^2 will be self-administered PO once every day, starting on Day 1, for 6 weeks. Then there will be a 4-week break after radiotherapy is complete.~Maintenance phase: Occurs thirty days (4 weeks) after receiving the last dose of radiotherapy. Temozolomide 150-200 mg/m\^2 will be self-administered PO BID, starting on Day 1 to Day 5 of each cycle for six cycles.~Either phase:~The dose may be reduced in the case of certain adverse events."

RADIATION

Radiation Therapy

Radiation will be administered every weekday (Monday to Friday) in 2 Gy fractions for 30 fractions during a 6-week period (60 Gy total).

Trial Locations (1)

33176

Miami Cancer Institute at Baptist Health, Inc., Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Incyte Corporation

INDUSTRY

lead

Baptist Health South Florida

OTHER