INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Reardon, MD
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Participants will not be eligible if the original diagnosis was a lower grade glioma and a subsequent histologic diagnosis revealed glioblastoma.
Planned major surgery.
Participants who are receiving any other investigational agents.
Participants who have had any prior cranial radiotherapy.
Trial design
Treatments tested in this trial
- Temozolomide
- Neratinib
- QBS10072S
- Abemaciclib
- CC-115
Treatment groups
460 Participants
are divided into 5 treatment groupsSponsors and collaborators
David Reardon, MD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Eli Lilly and Company
Collaborator
Celgene
Collaborator
Puma Biotechnology, Inc.
Collaborator
Accelerate Brain Cancer Cure
Collaborator
Quadriga Biosciences, Inc.
Collaborator
Source ClinicalTrials.gov