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|
| General |
| Study Status |
Redesigned/Replaced Study |
Application Number /
Requirement Number |
P100034 / PAS001 |
| Date Original Protocol Accepted |
04/08/2011
|
| Date Current Protocol Accepted |
02/09/2016
|
| Study Name |
New Enrollment Study for NovoTTF-100A
|
| Device Name |
NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
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| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study is a prospective, non-randomized open-label concurrent control study of NovoTTF-100A in recurrent GBM patients. A prospective, international, multi-center study, will include 30 centers in the US, EU and Israel, at least 15 centers in the US.
The study will include 2 groups: an Investigational Group composed of patients treated with the NovoTTF-100A and a Control Group of concurrent best standard of care chemotherapy.
Patients in the NovoTTF-100A group will be treated continuously until disease progression and then followed by telephone interview until death. Minimal recommended treatment duration is 4 weeks and minimal recommended treatment compliance is 18h/day (monthly average).
|
| Study Population |
The NovoTTF-100A System is intended as a treatment for adult
patients (22 years of age or older) with histologically-confirmed
glioblastoma multiforme (GBM), following histologically- or
radiologically-confirmed recurrence in the supra-tentorial
region of the brain after receiving chemotherapy.
NovoTTF-100A Group
¿ Patients treated with the NovoTTF-100A
¿ Patients will be treated continuously until disease
progression
¿ Minimal recommended treatment duration ¿ 4 weeks
¿ Minimal recommended treatment compliance ¿ 18h a day
(monthly average)
Control Group
¿ Concurrent best standard of care chemotherapy (control) group
|
| Sample Size |
30 centers in the US, EU and Israel. At least 15 centers in the
US.
Test arm: N1=243 NovoTTF-100A patients
Comparator arm: N2=243 Concurrent best standard of care
control patients
Definitions:
λ1 = hazard of death in the test arm
λ2 = hazard of death in the comparator arm
Primary Statistical Hypothesis:
H0: λ1 / λ2 > 1.375
H1: λ1 / λ2 ≤ 1.375
Assumptions:
Type I error: 0.05
Power: 0.80
Test statistics: Log-rank test
Lost to follow-up: 10%
|
| Key Study Endpoints |
Primary
¿ Overall survival (months)
Secondary
¿ Change in neuro-cognitive function from baseline based on the MMSE
¿ Genetic profiling of tumors and correlation with response
to NovoTTF-100A treatment, specifically:
o MGMT promoter methylation status
o EGFR amplification, over expression or rearrangement
o Chromosomes 1p/19q deletion status
o IDH1 mutation
¿ Adverse event incidence by body system and term,
including:
o Incidence of seizures and headaches
o Anticonvulsant use
|
| Follow-up Visits and Length of Follow-up |
¿ Recruitment: 48 months
¿ Follow-up: 12 months from recruitment of last patient
¿ NovoTTF-100A treatment until clinical disease progression.
¿ Patients will continue to be followed until death
Baseline:
¿ Eligibility assessment
¿ MMSE
¿ Genetic profiling of tumor tissue
¿ Adverse event symptoms
¿ Concomitant medication
Monthly until clinical disease progression:
¿ Vital status
¿ MMSE
¿ Adverse event record
¿ Concomitant medication (including steroid and anticonvulsant
dosing)
¿ Evaluation of progression
Monthly after disease progression:
¿ Vital status
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