Prexasertib in Recurrent Ovarian Cancer (JTJN)
Research type
Research Study
Full title
A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer
IRAS ID
239646
Contact name
Rowan Miller
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2017-004009-42
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Ovarian cancer is cancer of the ovary. Chemotherapy for ovarian cancer usually consists of a platinum compound and a taxane with or without bevacizumab. Although the tumours are initially chemo-sensitive, up to 80% of patients relapse and only 46% of patients survive 5 years from the time of diagnosis.
Therapy at the time of recurrence depends on the time elapsed since completing initial platinum-based chemotherapy: Platinum-sensitive patients relapse more than 6 months after platinum-based treatment whereas platinum-resistant patients relapsed within 6 months. Platinum-refractory disease patients progress during or within 4 weeks of the last dose of initial platinum-based chemotherapy.
There is not a clear standard of care for platinum-resistant or platinum-refractory disease with treatments varying by centre and geography and patients ultimately relapsing. New treatments are needed for platinum-resistant patients who have failed or exhausted standard treatment options.
Prexasertib has been evaluated as a treatment for patients with advanced cancers and may be beneficial both as a single treatment and in combination with other DNA-damaging agents, targeted agents or radiation.
Study I4D-MC-JTJN is a multicentre, nonrandomized, parallel cohort Phase 2 trial of prexasertib. This study is being conducted to find out if prexasertib can help patients with ovarian cancer and to monitor any side effects patients may have when they take prexasertib.
The study will include about 180 participants worldwide and 24 participants in the UK. Eligible participants will be assigned to one of 4 cohorts and will receive intravenous infusions of prexasertib once every 2 weeks for approximately 60 minutes. Study assessments will include questionnaires, blood, urine and pregnancy tests, physical examinations, ECGs (electrical tracings of the heart rhythm), tumour imaging assessments (MRI or CT scans) and tumour biopsies.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/0116
Date of REC Opinion
26 Mar 2018
REC opinion
Further Information Favourable Opinion