PRIMA UK
Research type
Research Study
Full title
A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Niraparib Maintenance Treatment in Patients with HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
IRAS ID
215441
Contact name
Amrit Rai
Contact email
Sponsor organisation
TESARO, Inc.
Eudract number
2015-000952-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 4 days
Research summary
This is a double-blind, randomised, placebo-controlled study of Niraparib maintenance treatment in patients with ovarian, primary peritoneal or fallopian tube cancer who have homologous recombination deficiency(HRD).
This study is being done to help find out if Niraparib, the study drug, can help delay worsening of cancer among patients who had a good response to previous treatment with a platinum-type chemotherapy drug
It is normal for our DNA to be damaged and then repaired every day by the cells in our body. Genetic mutations (changes) in the arrangement of genes are needed in order for DNA to fix itself. This process is called DNA repair. If this process is not done correctly then cancer may occur. An error-free DNA repair process, known as homologous recombination (HR)is needed to prevent mutations. Homologous recombination deficiency (HRD) is a test that measures whether the repair process is working correctly.Participants may only be eligible for randomisation if they have an HRD-positive tumour.
For eligible patients, a tumour sample will be collected and sent to a centralised laboratory for
immediate HRD testing. A previously collected tumour sample may be used, but if not available, a new sample will need to be collected. If a new sample is to be collected, participants will be asked to sign a separate consent. The sample may be sent in advance of the protocol-defined
screening period in order to facilitate the screening and enrolment process.Once a participant is randomised, oral Niraparib 300 mg (3 x 100 mg Niraparib capsules) or placebo will be administered once daily continuously in 28-day cycles. They will continue to take the medication until they reach disease progression.
Screening through the first 2 cycles will require 6 visits to the study site and thereafter each visit will take place about 4 weeks from the last visit.
Study duration will last approximately 49 weeks, but patients who are benefitting from treatment will have access to their assigned treatment as long as considered acceptable by their treating physician or until they are discontinued from treatment.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0653
Date of REC Opinion
7 Feb 2017
REC opinion
Further Information Favourable Opinion