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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Registry Study for Optune System


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General
Study Status Progress Adequate
Application Number P100034 / PAS002
Date Current Protocol Accepted 02/09/2016
Study Name OSB Lead-Registry Study for Optune System
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a new enrollment, non-randomized, open label, post-approval registry study of Optunein recurrent glioblastoma multiforme (GBM) patients. Treatment group is prospectively enrolled, the historica control ground is from the IDE study.

Primary objective:

To confirm that the efficacy of Optunein patients with recurrent GBM treated in a real life setting following approval is comparable to that of Best Standard of Care (BSC) chemotherapy patients in the pivotal trial.

Secondary objective:

•To collect additional data on the safety profile of the Optune in a real life setting

•To define Optune overall survival (months) by MGMT methylation status (where available).

•To define Optune overall survival (months) by baseline MMSE score (where available)

•To compare time to treatment failure (months) on Optune to that of BSC chemotherapy patients.

•To evaluate Optune functional impairment using Karnofsky Performance Score (KPS) (where available)

Study Population Description The treatment group will consist of 192 patients who will receive Optune monotherapyuntil clinical disease progression. Minimal recommended treatment duration – 4 weeks. Patients in the Optune group will be encouraged to use the device for at least 18 hours a day(monthly average). Patients will be enrolled through the PRiDe registry, sponsored by Novocure.

Best standard of care chemotherapy (control) group from the EF-11 pivotal study control group. The control arm consisted of the 117 BSC group patients. These patients were treated with the best standard of care chemotherapy available in the US at the time of the study.

Inclusion Criteria:

•22 years of age or older

•Histological diagnosis of GBM (WHO grade IV)

•Tumor located in the supra-tentorial region of the brain

•Received maximal, safe, surgical resection

•Received maximal radiation therapy (45-70Gy)

•Received concomitant Temozolomide (75mg/m^2/day for 6 weeks)

•Received maintenance Temozolomide (150-200 mg/m^2 daily for 5 days followed by 23 days without treatment for 6 cycles or until disease progression)

•Any recurrence (based on radiological or histological evidence of recurrence)

•Karnofsky performance score 70 or above

•Women of childbearing age must be on effective contraception

•Signed consent to use PHI in the Optune registry

Exclusion Criteria

•Implanted electronic medical device in the brain:

oDeep brain stimulator

oVagus nerve stimulator

oProgrammable shunt

•Skull defect without replacement

•Receiving concomitant chemotherapy

•Unable to comply with treatment with Optune

•Pregnant

•Actively participating in another therapeutic clinical trial

•Radiological suspicion of pseudoprogression or radionecrosis (a cold PET scan or negative biopsy are required in order to rule out these conditions if radiological suspicion exists)

•Any serious co-morbidity which is expected to affect survival more adversely than GBM

Sample Size Treatment arm: N1=192 Optunepatients

Comparator arm: N2=117 best standard of care control patients from the EF-11 pivotal study

Assumptions: ¿2 = 0.1083 (hazard of death in the recurrent GBM pivotal study BSC control group)

Type I error: 0.05

Power: 0.80

Test statistics: Log-rank test

Lost to follow-up: 10% in the Optune arm only

Data Collection Primary endpoint: Overall survival

Secondary endpoints:

• Adverse event incidence by body system and term,

• including:

o Incidence of seizures and headaches

• Overall survival (months) by MGMT methylation status (where available)

• Overall survival (months by baseline MMSE score (where available)

• Time to treatment failure (months)

Follow-up Visits and Length of Follow-up The range of follow-up is from 12 months to three years. Patients will be followed until death or the end of the study (up to three years). The last patient enrolled will be followed up to 12 months.





OSB Lead-Registry Study for Optune System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/08/2016 08/08/2016 On Time
one year report 02/09/2017 02/08/2017 On Time
18 month report 08/08/2017 08/08/2017 On Time
two year report 02/09/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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