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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
Histologically confirmed World Health Organization (WHO) grade IV glioma (GBM) or gliosarcoma, IDH wild-type
Documentation of MGMT unmethylated GBM per testing at any Clinical Laboratory Improvement Amendment (CLIA) certified laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

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 below
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My brain tumor is a grade IV glioma or gliosarcoma, IDH wild-type.
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My GBM is MGMT unmethylated according to a certified lab test.
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I've had brain surgery or a biopsy and no treatments after that.
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I can care for myself but may not be able to do active work.
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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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I will start treatment within 8 weeks after my last brain surgery.
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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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I am a woman who could still become pregnant.
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My brain tumor is a grade IV glioma or gliosarcoma, IDH wild-type.
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I had brain surgery or a biopsy and haven't received any treatment since.
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My GBM is MGMT unmethylated according to a certified lab test.
Select...
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.

Timeline

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

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 more
Other outcome measures
Alterations in tumor immune microenvironment
Pharmacodynamic properties of M3814

Awards & Highlights

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

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
2,945 Previous Clinical Trials
1,803,352 Total Patients Enrolled
42 Trials studying Glioblastoma
1,940 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,579 Previous Clinical Trials
41,224,450 Total Patients Enrolled
314 Trials studying Glioblastoma
22,755 Patients Enrolled for Glioblastoma
Nazanin Majd, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Nedisertib (DNA Damage Response Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04555577 — Phase 1
Glioblastoma Research Study Groups: Stage I (Peposertib, Radiation therapy, Temozolomide), Stage II (Peposertib, Radiation, Temozolomide, Surgery)
Glioblastoma Clinical Trial 2023: Nedisertib Highlights & Side Effects. Trial Name: NCT04555577 — Phase 1
Nedisertib (DNA Damage Response Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04555577 — Phase 1

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
~10 spots leftby Oct 2025