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.
Eligible Conditions
- Glioblastoma
- Gliosarcoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 7 Secondary · Reporting Duration: Up to 3 years
Day 10
Ability of nedisertib (M3814) to cross the blood brain barrier (Stage II)
Year 3
Median progression-free survival (Stage I)
Median progression-free survival (Stage II)
Up to 3 years
Alterations in tumor immune microenvironment
Median overall survival (Stage I)
Median overall survival (Stage II)
Overall response rate (Stage I)
Overall response rate (Stage II)
Pharmacodynamic properties of M3814
Week 10
Dose-limiting toxicities (DLT) (Stage I)
Maximum tolerated dose (MTD) (Stage I)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Stage II (nedisertib, radiation, temozolomide, surgery)
1 of 2
Stage I (nedisertib, radiation therapy, temozolomide)
1 of 2
Experimental Treatment
29 Total Participants · 2 Treatment Groups
Primary Treatment: Radiation Therapy · No Placebo Group · Phase 1
Stage II (nedisertib, radiation, temozolomide, surgery)Experimental Group · 4 Interventions: Radiation Therapy, Resection, Temozolomide, Nedisertib · Intervention Types: Radiation, Procedure, Drug, Drug
Stage I (nedisertib, radiation therapy, temozolomide)Experimental Group · 3 Interventions: Radiation Therapy, Temozolomide, Nedisertib · Intervention Types: Radiation, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2005
Completed Phase 3
~7010
Resection
2021
Completed Phase 2
~400
Temozolomide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,098 Previous Clinical Trials
41,145,748 Total Patients Enrolled
303 Trials studying Glioblastoma
22,486 Patients Enrolled for Glioblastoma
M.D. Anderson Cancer CenterLead Sponsor
2,810 Previous Clinical Trials
1,790,542 Total Patients Enrolled
41 Trials studying Glioblastoma
1,925 Patients Enrolled for Glioblastoma
Nazanin MajdPrincipal InvestigatorM.D. Anderson Cancer Center
Nazanin Majd, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients who have had brain surgery or a biopsy and have not received any further treatments are eligible to participate in this study.
at diagnosis
The person has a Karnofsky performance status of >= 60 or Eastern Cooperative Oncology Group of <= 2 at diagnosis.
People must start treatment within 8 weeks of having a brain surgical procedure
ANC of at least 1,500 per microliter within 14 days of the start of the study.
The subject must have a platelet count of at least 100,000 cells/microliter within 14 days prior to the first day of the study.
WHO grade IV glioma tumors, which are also called glioblastomas, are very aggressive and difficult to treat
is sufficient to support a diagnosis of unmethylated GBM
Any documentation of MGMT unmethylated GBM from a Clinical Laboratory Improvement Amendment (CLIA) certified laboratory can be used to support a diagnosis of unmethylated GBM.
A baseline MRI of the brain was obtained less than 2 weeks before the start of the study for participants who were currently taking a stable or tapering dose of steroids no more than 4 mg a day of dexamethasone (or equivalent dose of other steroids) for at least 3 days.
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Conditions
Cancer Related
Treatments