INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

Conditions

• Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Temozolomide — DRUG
  Temzolomide capsules
• Neratinib — DRUG
  Neratinib tablets
• QBS10072S — DRUG
  QBS10072S administered intravenously
• Abemaciclib — DRUG
  Abemaciclib tablets
• CC-115 — DRUG
  CC-115 tablets

Study Details

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

Key Dates

Start date

Feb 9, 2017

Status verified

Oct 2025

Primary completion

Feb 1, 2028

Completion

Apr 30, 2028

Study Design

Enrollment

460 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Temozolomide
  * Daily Radiation for a maximum of 49 days. * Temozolomide will be administered orally on a daily dosing schedule * Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy * Temozolomide will also be administered post radiation for up to 6 cycles (5 days/cycle)
• Experimental: Neratinib with Temozolomide
  * Daily Radiation for a maximum of 49 days. * Temozolomide will be administered orally on a daily dosing schedule * Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy * Neratinib will be taken post radiation at a daily oral pre-determine dose
• Experimental: QBS10072S
  Daily Radiation for a maximum of 49 days. QBS10072S will be administered on Day 1 of Radiation Treatment QBS10072S will be administered post- radiation for up to 6 cycles
• Experimental: Abemaciclib with Temozolomide
  * Daily Radiation for a maximum of 49 days. * Temozolomide will be administered orally on a daily dosing schedule during radiation * Temozolomide will be administered approximately 2-3 hours before each session of radiotherapy * Abemaciclib will be taken post radiation at a twice daily oral pre-determined dose
• Experimental: CC-115
  * Twice daily oral dosing of CC-115 * Daily Radiation for a maximum of 49 days * CC115 will also be taken twice daily post radiation

Primary Outcome Measure

Overall Survival in Experimental Arms Compared with Standard Therapy [ Time Frame: 2 years ]

Central Contacts

• Patrick Y Wen, MD
  617-632-2166
  [email protected]
• Lisa Doherty, NP
  617-632-2166
  [email protected]

Locations (12)

Find similar trials in Birmingham, AL

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