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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enrollment Study for NovoTTF-100A


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General
Application Number P100034 / PAS001
Current Plan Approved 02/09/2016
Study Name OSB Lead-New Enrollment Study for NovoTTF-100A
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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 Description 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%

Data Collection 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



OSB Lead-New Enrollment Study for NovoTTF-100A Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/07/2011 11/28/2011 Overdue/Received
one year report 04/07/2012 06/13/2012 Overdue/Received
18 month report 10/06/2012 10/26/2012 Overdue/Received
two year report 05/08/2013 05/02/2013 On Time
three year report 04/07/2014 08/08/2014 Overdue/Received
four year report 04/07/2015 04/20/2015 Overdue/Received


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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