NCT02977780 · Patrick Wen, MD
INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
What this study is about
This research study is studying several experimental drugs as a possible treatment for Glioblastoma (GBM).
View original scientific description
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM).
Interventions
DRUG
Temozolomide
Temzolomide capsules
DRUG
Neratinib
Neratinib tablets
DRUG
QBS10072S
QBS10072S administered intravenously
DRUG
Abemaciclib
Abemaciclib tablets
DRUG
CC-115
CC-115 tablets
Primary outcome measures
Overall Survival in Experimental Arms Compared with Standard Therapy
Time frame: 2 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must have histologically confirmed intracranial glioblastoma or gliosarcoma following maximum surgical resection. Tumors primarily localized in the infratentorial compartment will be excluded.
- Participants may have had prior surgery for glioblastoma or gliosarcoma but no systemic or radiation therapy.
- Age ≥ 18 years.
- Karnofsky performance status ≥60
- Participants must have normal organ and marrow function as defined below:
- Leukocytes ≥3,000/mL
- Absolute neutrophil count ≥1,500/mL
- Platelets ≥100,000/mL
- Hemoglobin ≥ 9g/dl
- Total bilirubin within normal institutional limits (except for participant's with Gilbert's disease)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal
- Creatinine ≤ institutional upper limit of normal OR
- Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Potassium within normal institutional range, or correctable with supp
Where
- Birmingham, Alabama
- Boston, Massachusetts
- Rochester, Minnesota
- New York, New York
- Cleveland, Ohio
- Pittsburgh, Pennsylvania
- Providence, Rhode Island
- Houston, Texas
- Salt Lake City, Utah
- Charlottesville, Virginia
Collaborators
Eli Lilly and Company, Celgene, Puma Biotechnology, Inc., Accelerate Brain Cancer Cure, Quadriga Biosciences, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations