Actively Recruiting
INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
Led by Patrick Wen, MD · Updated on 2025-11-10
460
Participants Needed
12
Research Sites
585 weeks
Total Duration
On this page
Sponsors
P
Patrick Wen, MD
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : * Abemaciclib (arm is currently closed to accrual) * Temozolomide (temodar) * Neratinib (arm is currently closed to accrual) * CC115 (arm is currently closed to accrual) * QBS10072S
CONDITIONS
Official Title
INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed intracranial glioblastoma or gliosarcoma after maximum surgical removal, with tumors not primarily in the infratentorial compartment
- Participants may have had prior surgery but no prior systemic or radiation therapy for glioblastoma or gliosarcoma
- Age 18 years or older
- Karnofsky performance status of 60 or higher
- Normal organ and marrow function including specific blood counts and liver, kidney, and coagulation parameters
- Ability to swallow pills
- Planning to begin radiation therapy 14 to 42 days after surgery
- Negative for IDH1 R132H mutation by immunohistochemistry
- Evidence of unmethylated MGMT promoter by standard assays
- Genotyping data available or in process for biomarker subgroup assignment
- MRI with gadolinium obtained within 21 days before treatment start
- Women of childbearing potential and men must agree to use adequate contraception during the study
- Negative pregnancy test for women of childbearing potential before enrollment
- Ability and willingness to provide informed consent
You will not qualify if you...
- Original diagnosis of lower grade glioma with later diagnosis of glioblastoma
- Planned major surgery
- Receiving any other investigational agents
- Prior cranial radiotherapy
- Planned use of Optune™ device
- History of other malignancies unless disease-free for at least 2 years or specific low-risk cancers treated
- Significant intratumoral or peritumoral hemorrhage
- Impaired cardiac function or serious cardiac diseases including recent myocardial infarction, unstable angina, or arrhythmias
- Known congenital QT prolongation or torsade de pointes
- Uncontrolled hypertension or diabetes
- Active infections or chronic illnesses that interfere with study participation
- Known active Hepatitis B or C
- Acute or chronic pancreatitis
- Active diarrhea of grade 2 or higher despite treatment
- Pregnancy or breastfeeding
- Gastrointestinal conditions affecting drug absorption
- Allergic reactions to study drugs or similar compounds
- Use of enzyme-inducing anti-epileptic drugs unless stopped 7 days before treatment
- Use of strong CYP3A inhibitors or inducers unless stopped 7 days before treatment
- Use of certain herbal medications unless stopped 7 days before treatment
- Use of warfarin or coumadin derivatives unless stopped 7 days before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Active, Not Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
5
Columbia University Medical Center
New York, New York, United States, 10032
Active, Not Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
8
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
9
Lifespan / Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Active, Not Recruiting
10
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Completed
11
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Active, Not Recruiting
12
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Completed
Research Team
P
Patrick Y Wen, MD
CONTACT
L
Lisa Doherty, NP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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