Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Temozolomide

    Drug

    Temzolomide capsules

  • Neratinib

    Drug

    Neratinib tablets

  • QBS10072S

    Drug

    QBS10072S administered intravenously

  • Abemaciclib

    Drug

    Abemaciclib tablets

  • CC-115

    Drug

    CC-115 tablets

Treatment groups

460 Participants
are divided into 5 treatment groups
Group A: TemozolomideActive comparator 1 intervention
Group B: Neratinib with TemozolomideExperimental treatment 2 interventions
Group C: QBS10072SExperimental treatment 1 intervention
Group D: Abemaciclib with TemozolomideExperimental treatment 2 interventions
Group E: CC-115Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival in Experimental Arms Compared with Standard Therapy

Time frame
2 years

Secondary outcomes

1

Incidence of Treatment-Emergent Adverse Events

Safety will be assessed by quantifying the toxicities and grades experienced by subjects, including serious adverse events (SAEs). The following will also be measured as part of safety: laboratory safety assessments, KPS status, vital signs and physical examinations.

Time frame
2 years
2

Progression Free Survival Among Experimental Arms And Biomarker Groups

Time frame
2 years
3

Overall Survival Among Experimental Arms And Biomarker Groups

Time frame
2 years
4

Association Between Progression Free Survival and Overall Survival Effects Of Experimental Agents

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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