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TTFields

Phase 2

Glioblastoma Multiforme | Unknown | Oncology |NovoCure Limited|Last Updated: Aug 16, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

TTFields · 1 trial · 1 indication

Phase 2 1
NCT04492163Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBMGlioblastoma Multiforme
COMPLETED25 Analytics
PHASE2COMPLETED
Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM
Glioblastoma MultiformeUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression free survival (PFS)
18 Months

PFS will be measured from the date of enrollment to date of progression (in months) based on RANO citeria.

Secondary Endpoints

Overall Survival (OS)
18 Months
Progression Free Survival at 6 months (PFS6)
18 Months
1-year and 2-year survival rates
24 Months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental: TTFieldsEXPERIMENTALPatients receive continuous TTFields treatment using the Optune® System with high intensity transducer arrays.

Interventions

NameTypeDescription
TTFieldsDEVICETTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine. Other Names: • TTFields
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically confirmed diagnosis of GBM according to WHO classification criteria. 2. Age ≥ 18 years 3. Not a candidate for further radiotherapy or additional resection of residual tumor. 4. Patients with first or second radiological disease progression per RANO criteria doc...

Countries:Czechia
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Frequently asked questions about TTFields

What is TTFields used for in Glioblastoma Multiforme?

TTFields is an investigational oncology therapy being studied for the treatment of Glioblastoma Multiforme (GBM), a type of brain cancer. It is currently in Phase 2 clinical development. The therapy is delivered using the OPTUNE device with high density transducer arrays, as evaluated in a completed pilot study for recurrent GBM.

Who makes TTFields?

TTFields is being developed by NovoCure Limited, a company publicly traded under the ticker symbol NVCR. NovoCure is conducting clinical research on this therapy for Glioblastoma Multiforme. The company's development program includes a completed Phase 2 pilot study of the OPTUNE device with high density transducer arrays.

What phase is TTFields in?

TTFields is in Phase 2 clinical development for Glioblastoma Multiforme. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The therapy is being studied in a completed open-label pilot trial that enrolled 25 patients with recurrent GBM.

What clinical trials is TTFields in?

TTFields has been studied in one clinical trial, identified as NCT04492163. This was a Phase 2, open-label pilot study titled 'Open-Label Pilot Study of OPTUNE With High Density Transducer Arrays for the Treatment of Recurrent GBM.' The trial was completed and enrolled 25 participants in Czechia.

Is TTFields the same as OPTUNE?

TTFields is the therapy being investigated, and OPTUNE is the device used to deliver it. In the clinical trial NCT04492163, the treatment involved OPTUNE with high density transducer arrays for recurrent Glioblastoma Multiforme. The trial was an open-label, uncontrolled pilot study that has been completed.