NCT02977780

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Patrick Wen, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the study drug works in treating a specific disease. "Investigational" means that the drug is being studied. In this research study, the investigators are looking to compare the effects, good and bad, of the standard of care with the three investigational agent sub-studies Abemaciclib, Neratinib, CC115, QBS10072S to help people with Glioblastoma including the specific molecular changes in the genes and proteins. The FDA has approved Temozolomide (temodar) as a treatment for this disease, however the FDA has not approved Abemaciclib, CC115, Neratinib, QBS10072S for any diseases.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Temzolomide capsules
DRUG	Neratinib	Neratinib tablets
DRUG	QBS10072S	QBS10072S administered intravenously
DRUG	Abemaciclib	Abemaciclib tablets
DRUG	CC-115	CC-115 tablets

Timeline

• Start date: 2017-02-09
• Primary completion: 2028-02-01
• Completion: 2028-04-30
• First posted: 2016-11-30
• Last updated: 2025-11-10

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study