Adavosertib + Radiation + Temozolomide for Glioblastoma

Recruiting at 11 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must be taking: Corticosteroids

Must not be taking: EIAEDs, CYP3A4 inhibitors

Disqualifiers: Pregnancy, HIV, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

74 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Eudocia Q Lee

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initiation Cycle

Patients receive adavosertib and temozolomide with concurrent radiation therapy for 6 weeks

6 weeks

5 visits per week (in-person)

Maintenance Cycles

Patients receive temozolomide every 28 days for up to 6 cycles

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 2 months for 2 years, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Adavosertib
• Radiation Therapy
• Temozolomide

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.

How Is the Trial Designed?

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+