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MDM2 Inhibitor

Navtemadlin for Brain Cancer

Boston, MA
Phase 1
Waitlist Available
Led By Eudocia Lee
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be 18 years of age or older
Part 1 patients must have prior histologically proven glioblastoma that is progressive or recurrent following radiation therapy +/- chemotherapy
Must not have
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AMG 232 (KRT 232); in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
Part 1 patients who have not recovered to < Common Terminology Criteria for Adverse Events (CTCAE) grade 2 toxicities related to prior therapy are ineligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies navtemadlin to see if it can help patients with brain cancer. Navtemadlin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Navtemadlin may cause side effects like blocking enzymes needed for cell growth which could lead to various reactions depending on how it interacts with the tumor cells and surrounding healthy tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My glioblastoma has returned or worsened after radiation or chemotherapy.
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My kidney function is good based on a creatinine clearance test.
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I can take care of myself with some help.
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My tumor is MGMT unmethylated according to standard tests.
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My diagnosis is glioblastoma or gliosarcoma.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV-positive and not on antiretroviral therapy.
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I have recovered from major side effects of my previous treatments.
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I can take oral medications and do not have GI diseases affecting absorption.
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I do not have a history of unusual bleeding.
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I do not have active hepatitis B or C.
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I have no allergies to AMG 232 or similar medications.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) of MDM2 inhibitor AMG 232 (KRT-232) when combined with concomitant radiation therapy (Part 2)
Pharmacokinetics (PK) parameters with target inter-tumor drug concentration at >= 25 nm (Part 1)
Secondary study objectives
Incidence of adverse events (Part 1)
Incidence of adverse events (Part 2)
MDM2 inhibitor AMG 232 (KRT-232) exposure (Part 2)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (MDM2 inhibitor AMG 232 [KRT-232])Experimental Treatment4 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2004
Completed Phase 3
~7740
Biospecimen Collection
2004
Completed Phase 3
~1810
Magnetic Resonance Imaging
2020
Completed Phase 3
~1180

Find a Location

Closest Location:UPMC-Shadyside Hospital· Pittsburgh, PA· 163 miles

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
14,039 Previous Clinical Trials
41,146,643 Total Patients Enrolled
331 Trials studying Glioblastoma
23,247 Patients Enrolled for Glioblastoma
Eudocia LeePrincipal InvestigatorNational Cancer Institute (NCI)

Media Library

Navtemadlin (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03107780 — Phase 1
Glioblastoma Research Study Groups: Treatment (MDM2 inhibitor AMG 232 [KRT-232])
Glioblastoma Clinical Trial 2023: Navtemadlin Highlights & Side Effects. Trial Name: NCT03107780 — Phase 1
Navtemadlin (MDM2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03107780 — Phase 1
~4 spots leftby Mar 2026
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