Navtemadlin for Brain Cancer

Recruiting at 10 trial locations

Overseen By Roy E. Strowd

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 phase I trial studies the side effects and best dose of navtemadlin in treating patients with glioblastoma (brain cancer) that is newly diagnosed or has come back (recurrent). Navtemadlin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Eudocia Lee

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for adults with newly diagnosed or recurrent glioblastoma who can swallow pills, have a certain level of physical function (Karnofsky status >= 60%), and normal organ function. Women must not be pregnant and agree to contraception. No other cancer treatments are allowed close to the start of the trial, and no history of severe allergies to similar drugs.

Inclusion Criteria

Creatinine =< institutional ULN

Patients must have MRI within 21 days before starting treatment; patients must be able to tolerate MRI with gadolinium

My glioblastoma has returned or worsened after radiation or chemotherapy.

Exclusion Criteria

I am not taking any medication that reacts badly with the trial drug.

I am HIV-positive and not on antiretroviral therapy.

I have recovered from major side effects of my previous treatments.

Treatment Details

Interventions

• Navtemadlin (MDM2 Inhibitor)

Trial Overview The study tests navtemadlin's safety, tolerable doses, and its ability to reach brain tumors in patients undergoing radiation therapy. It includes MRI scans and biospecimen collection to assess how well navtemadlin works against glioblastoma.

Participant Groups

Group I: Treatment (MDM2 inhibitor AMG 232 [KRT-232]) Experimental Treatment 4 Interventions

See Detailed Description

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+