A phase II study of abiraterone in patients with recurrent ovarian, fallopian, or primary peritoneal cancer.
Disease site: Ovarian cancer
Treatment modality: Systemic therapy
Status: In follow up
CORAL is a phase II, prospective, multicentre, open label, two stage trial to determine whether the drug abiraterone has clinical activity in patients with ovarian cancer that has relapsed within 12 months of treatment.
A total of 47 evaluable patients will be recruited from sites across the UK. Stage one of CORAL will recruit 26 patients, and if this is successful, stage two of the trial will recruit a further 21 patients. All participants will receive abiraterone 1000mg daily until progression and the number of patients taking part with androgren receptor positive disease will be carefully monitored.
If CORAL shows that abiraterone is a promising drug in this tumour group, the results could be used to design a follow on phase III multicentre randomised controlled trial.
Chief Investigator: Dr Susana Banerjee, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Judith Bliss
Trial management contact: [email protected]
Co-sponsors: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
Funding: Janssen-Cilag Ltd and endorsed by Cancer Research UK’s Clinical Trials Awards & Advisory Committee (CRUKE/12/052)
Further information including recruitment progress is available from the UK Clinical Trials Gateway.
A plain English summary of the CORAL trial is available from Cancer Research UK.
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