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DNA Damage Response Inhibitor
Peposertib + Radiation + Temozolomide for Glioblastoma/Gliosarcoma
Phase 1
Recruiting
Led By Nazanin Majd, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A baseline magnetic resonance imaging (MRI) of brain obtained no more than 14 days prior to study enrollment on a stable or tapering dose of steroids no greater than 4 mg a day of dexamethasone (or equivalent dose of other steroids) for at least 3 days
Documentation of MGMT unmethylated GBM per testing at any CLIA certified laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new drug, nedisertib, to see if it can help shrink tumors when used with radiation therapy in patients with a certain type of brain cancer.
Who is the study for?
This trial is for adults with newly diagnosed MGMT unmethylated glioblastoma or gliosarcoma who have had surgery but no other treatments. They must be able to follow the study plan, have proper kidney and liver function, normal blood counts, and a stable condition on low-dose steroids. Women of childbearing age need a negative pregnancy test and agree to use birth control; men also need to use contraception.Check my eligibility
What is being tested?
The trial tests Peposertib combined with radiation therapy followed by Temozolomide chemotherapy in patients with specific brain tumors. It aims to find the best dose of Peposertib that can be given safely and see if this combination works better than standard treatment alone.See study design
What are the potential side effects?
Possible side effects include reactions related to Peposertib such as fatigue, nausea, skin changes from radiation, and typical chemotherapy-related issues like hair loss, lowered blood cell counts increasing infection risk, mouth sores, and constipation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had a brain MRI within the last 14 days and am on a low or reducing dose of steroids.
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My GBM is MGMT unmethylated according to a certified lab test.
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I am a woman who could still become pregnant.
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My kidney function is within the required range for the study.
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I am using two forms of birth control or am surgically sterile.
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My brain tumor is a grade IV glioma or gliosarcoma, IDH wild-type.
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I can care for myself and perform daily activities.
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I've had a brain MRI within the last 2 weeks and am on a low or reducing dose of steroids.
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I can care for myself but may not be able to do active work.
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My GBM is MGMT unmethylated according to a certified lab test.
Select...
My brain tumor is a grade IV glioma or gliosarcoma, IDH wild-type.
Select...
I've had brain surgery or a biopsy and no treatments after that.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability of Peposertib (M3814) to cross the blood brain barrier (Stage II)
Maximum tolerated dose (MTD) (Stage I)
Secondary outcome measures
Dose-limiting toxicities (DLT) (Stage I)
Median overall survival (Stage I)
Median overall survival (Stage II)
+4 moreOther outcome measures
Alterations in tumor immune microenvironment
Pharmacodynamic properties of M3814
Trial Design
2Treatment groups
Experimental Treatment
Group I: Stage II (Peposertib, Radiation, Temozolomide, Surgery)Experimental Treatment4 Interventions
CONCURRENT: Patients receive Peposertib and undergo standard of care radiation therapy as in Stage I. Within 1-14 days after the completion of radiation therapy, patients undergo surgical resection.
ADJUVANT: Patients receive temozolomide as in Stage I.
Group II: Stage I (Peposertib, Radiation therapy, Temozolomide)Experimental Treatment3 Interventions
CONCURRENT: Patients undergo standard of care radiation therapy daily (Monday-Friday) for 30 fractions. Patients also receive Peposertib PO on each day of radiation therapy and given 1-2 hours before each treatment fraction. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
ADJUVANT: 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peposertib
2021
Completed Phase 1
~20
Radiation Therapy
2017
Completed Phase 3
~7250
Resection
2021
Completed Phase 2
~410
Temozolomide
2010
Completed Phase 3
~1930
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,367 Total Patients Enrolled
42 Trials studying Glioblastoma
1,940 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,103 Total Patients Enrolled
322 Trials studying Glioblastoma
23,086 Patients Enrolled for Glioblastoma
Nazanin Majd, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that would make the treatment risky for me.I have a condition that increases my risk for side effects from radiation.I do not have any health issues that would prevent me from following the study's requirements.I've had a brain MRI within the last 14 days and am on a low or reducing dose of steroids.I had surgery to remove a brain tumor and no visible tumor remains, or it's in a place that can't be surgically removed.My GBM is MGMT unmethylated according to a certified lab test.I have not received a live flu vaccine recently and won't during the study.I haven't had any other cancers in the last 5 years, except for those considered low risk and curable.I am a woman who could still become pregnant.I am a stage I patient who might need surgery as decided by my doctors after radiation therapy.I am not taking drugs that strongly affect certain liver enzymes or specific drug transporters.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I do not expect to need major surgery during the study, except if it's a planned non-urgent brain surgery.My cancer has spread to specific areas of my brain or outside the brain.I have been treated with drugs that target cancer cell DNA repair mechanisms.You have previously taken part in a clinical trial for a new treatment for glioblastoma, or are currently participating in one.I will start treatment within 8 weeks after my last brain surgery.I have a history of HIV infection.I am taking antibiotics to prevent infection.Your blood test done within 14 days prior to the start of the study shows that you have enough infection-fighting white blood cells (ANC) in your body.I am eligible for and consent to surgery after treatment for my Stage II condition.You cannot have an MRI scan for medical reasons.Your platelet count needs to be at least 100,000 per microliter within 14 days before the start of the study.I have a history of long QT syndrome.I have not taken antibiotics for an infection in the last 2 weeks.You have a mental health or drug abuse problem that may prevent you from following the trial requirements.I have issues swallowing or a gut condition that affects medication absorption.I am not receiving other cancer treatments while in this study.I am not using H2 blockers or PPIs, or I can stop them 4 days before treatment.You are willing and able to follow the rules of the study.I agree to use birth control during the study.My kidney function is within the required range for the study.I am a woman who can have children and have a negative pregnancy test within the last 14 days.I am using two forms of birth control or am surgically sterile.My brain tumor is a grade IV glioma or gliosarcoma, IDH wild-type.I can care for myself and perform daily activities.I've had a brain MRI within the last 2 weeks and am on a low or reducing dose of steroids.I can care for myself but may not be able to do active work.My GBM is MGMT unmethylated according to a certified lab test.My brain tumor is a grade IV glioma or gliosarcoma, IDH wild-type.You have read and signed a document that explains the study and your participation in it.My cancer's MGMT status has been tested and is methylated.I have had specific local treatments for my cancer, but not Gliadel wafers, LITT, or Optune.I've had brain surgery or a biopsy and no treatments after that.
Research Study Groups:
This trial has the following groups:- Group 1: Stage I (Peposertib, Radiation therapy, Temozolomide)
- Group 2: Stage II (Peposertib, Radiation, Temozolomide, Surgery)
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.
How many participants is this trial recruiting?
"Yes, the clinicaltrials.gov website affirms that this medical trial is actively recruiting patients as of now. It was initially posted on September 20th 2020 and last modified on September 27th 2022; it desires 29 participants from 1 location."
Answered by AI
What pathologies are most frequently treated with Radiation Therapy?
"Radiotherapy is frequently used for nitrosourea treatment, but also can be beneficial in managing refractory advanced mycosis fungoides, advance directives, and intractable neuroblastoma."
Answered by AI
Has the FDA sanctioned Radiation Therapy as a viable treatment option?
"Taking into account the limited available data, Radiation Therapy was judged to have a score of 1."
Answered by AI
Is this clinical trial a pioneering endeavor?
"At the moment, there are 209 active studies involving Radiation Therapy in 36 nations and 937 cities. This research was initially initiated by Schering-Plough back in 2002 with 60 participants, culminating in a Phase 2 drug approval stage. Subsequently, another 402 trials have been conducted since then."
Answered by AI
Are there any antecedent experiments involving Radiation Therapy?
"Presently, there are 209 Radiation Therapy studies with 23 of them being in Phase 3. A majority of these trials is based in Seoul and Songpa; however, 4787 medical centres worldwide offer this treatment."
Answered by AI
Is there a current enrollment initiative for this medical trial?
"Affirmative. In accordance with information accessible on clinicaltrials.gov, this medical study is currently in search of participants and was originally posted on September 20th 2020. The trial requires up to 29 individuals from a single site for completion."
Answered by AI
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