Adavosertib + Radiation + Temozolomide for Glioblastoma

Recruiting at 11 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests the safety and best dose of adavosertib combined with radiation and temozolomide for treating glioblastoma. Adavosertib blocks enzymes needed for tumor growth, while radiation and temozolomide kill cancer cells and stop them from growing. The study aims to find the most effective dose and understand how well this combination works for patients with newly diagnosed or recurrent glioblastoma.

Research Team

Eudocia Q Lee

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for adults with new or recurrent glioblastoma who can provide tissue samples, have a decent performance status (able to care for themselves), normal organ and marrow function, no severe allergies to similar drugs, and not on certain medications. Women must test negative for pregnancy and agree to birth control.

Inclusion Criteria

Total bilirubin =< institutional upper limit of normal

AST/ALT =< 3 x institutional upper limit of normal

APTT/PTT =< 1.5 x institutional upper limit of normal

Exclusion Criteria

Patients receiving any other investigational agents are ineligible

Pregnant women are excluded from this study

I am not on any blood thinners except for low-molecular weight heparin.

Treatment Details

Interventions

• Adavosertib (ATR Kinase Inhibitor)
• Radiation Therapy (Radiation)
• Temozolomide (Alkylating Agent)

Trial Overview The trial tests the combination of adavosertib with radiation therapy and temozolomide chemotherapy in patients with glioblastoma. It aims to find the best dose of adavosertib that's effective when used alongside standard treatments without causing severe side effects.

Participant Groups

Group I: Arm II (adavosertib, temozolomide) Experimental Treatment 2 Interventions

Patients receive adavosertib PO QD on days 1, 3, and 5 or 1-5 weekly, and temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (adavosertib, temozolomide, radiation) Experimental Treatment 3 Interventions

INITIATION CYCLE: Patients receive adavosertib PO on days 1, 3, and 5 or 1-5 weekly and temozolomide PO QD for 6 weeks. Patients also undergo concurrent radiation therapy 5 days per week for 6 weeks. MAINTENANCE CYCLES: Beginning in week 10, patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+