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MDM2 Inhibitor
Navtemadlin for Brain Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Incidence of adverse events (Part 1)
Incidence of adverse events (Part 2)
MDM2 inhibitor AMG 232 (KRT-232) exposure (Part 2)
+3 moreTrial 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
2017
Completed Phase 3
~7250
Biospecimen Collection
2004
Completed Phase 2
~1700
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,355 Total Patients Enrolled
323 Trials studying Glioblastoma
23,062 Patients Enrolled for Glioblastoma
Eudocia LeePrincipal InvestigatorNational Cancer Institute (NCI)
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My glioblastoma has returned or worsened after radiation or chemotherapy.I am scheduled for a necessary repeat surgery as advised by my doctor.I have a signed form by a pathologist for my glioblastoma tissue from initial surgery.I can swallow pills.My steroid medication dose has been stable for at least 5 days before my MRI scan.I have no other cancers except possibly skin cancer or early-stage cervical, breast, or bladder cancer.I am not taking warfarin, factor Xa inhibitors, or direct thrombin inhibitors for blood clots.I can take oral medications and do not have GI diseases affecting absorption.I do not have a history of unusual bleeding.I do not have active hepatitis B or C.My kidney function is good based on a creatinine clearance test.I can take care of myself with some help.My hemoglobin level is at least 10 g/dL.I am not pregnant, will use birth control during the study, and will inform my doctor if I become pregnant.I have had multiple treatments for my condition before.I have recovered from any serious side effects of my previous cancer treatments.I am not currently taking any epilepsy drugs that speed up drug breakdown.I have recovered from my recent surgery.I haven't had any treatment for my brain tumor except for glucocorticoids.I do not have any serious illnesses or heart problems that are not under control.I am not pregnant or breastfeeding.I am 18 years old or older.I have no allergies to AMG 232 or similar medications.I am not using herbal or non-traditional medications.My tumor is MGMT unmethylated according to standard tests.My diagnosis is glioblastoma or gliosarcoma.I haven't taken any medications that affect heart rhythm, except for ondansetron, in the last week.My cancer has a normal p53 gene according to DNA tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (MDM2 inhibitor AMG 232 [KRT-232])
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
Wake Forest University Health Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Newly diagnosed what to try sometime before I’m disqualified.
PatientReceived 2+ prior treatments
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