CORAL: Cancer of the OvaRy Abiraterone triaL

ISRCTN	ISRCTN63407050
DOI	https://doi.org/10.1186/ISRCTN63407050
Clinical Trials Information System (CTIS)	2013-000293-29
Protocol serial number	ICR-CTSU/2012/10038
Sponsor	The Institute of Cancer Research (UK)
Funders	Study drug and funding provided by Janssen-Cilag, CORAL has received endorsement from Cancer Research UK (CRUK) (ref: A16037)

Submission date: 03/04/2013
Registration date: 24/05/2013
Last edited: 09/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-abiraterone-for-women-with-ovarian-primary-peritoneal-or-fallopian-tube-cancer-coral

Contact information

Dr Susana Banerjee
Scientific

The Royal Marsden NHS Foundation Trust
Gynaecology Unit
Downs Road
Sutton
London
SM2 5PT
United Kingdom

Email	coral-icrctsu@icr.ac.uk

Study information

Primary study design	Interventional
Study design	Prospective open-label non-randomised two-stage phase II clinical trial
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title	A phase II study of abiraterone in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer
Study acronym	CORAL
Study objectives	The study hypothesis is that abiraterone will show clinical activity in patients with epithelial ovarian cancer (EOC). We also aim to identify biomarkers of abiraterone sensitivity in EOC and evaluate the molecular impact of abiraterone.
Ethics approval(s)	NRES Committee London – Westminster, 22/10/2013, REC ref: 13/LO/1599
Health condition(s) or problem(s) studied	Patients with epithelial ovarian cancer (including fallopian tube and primary peritoneal) that has relapsed within 12 months of last treatment.
Intervention	Evaluating the efficacy of abiraterone in patients with ovarian, including fallopian tube and primary peritoneal, cancer. Oral abiraterone 1000mg (4x250mg) plus 5mg prednisone/prednisolone once a day Patients will continue on trial treatment until disease progression. We anticipate the study running for around 3 years, from first patient recruited to last patient last data capture Details of co-sponsor: Royal Marsden NHS Foundation Trust R&D Office Royal Marsden Hospital Downs Road Sutton United Kingdom
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Abiraterone
Primary outcome measure(s)	The primary objective of this study is to determine whether abiraterone has clinical activity (objective response rate assessed by imaging and/or CA125 tumour marker changes in the blood) in patients with epithelial ovarian cancer.
Key secondary outcome measure(s)	1. The proportion of patients with objective response according to RECIST 2. The proportion of patients with objective response according to GCIG (CA125) 3. Clinical benefit rate according to RECIST/GCIG criteria at 12 weeks 4. Progression Free Survival (PFS) 5. 6-month PFS 6. Time to Progression (TTP) 7. Overall survival (OS) 8. Toxicity according to CTCAE version 4.0 We will also explore the molecular impact of abiraterone and attempt to identify biomarkers of abiraterone sensitivity in epithelial ovarian cancer.
Completion date	14/07/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	47
Total final enrolment	42
Key inclusion criteria	1. Histologically or cytologically confirmed epithelial ovarian, fallopian tube (FT) or primary peritoneal (PP) cancer and have progressed (radiological or CA125 criteria) within 12 months of last systemic anti-cancer therapy 2. Life expectancy of at least 12 weeks 3. Post-menopausal defined as: 3.1. Aged ≥ 18 years having had bilateral salpingo-oophorectomy (BSO) 3.2. Aged ≥ 45 years with intact uterus and amenorrhoeic for at least 12 months 3.3. FSH >40 U/L in patients who have had a hysterectomy and ovaries are intact (i.e. not had bilateral oophorectomy) Documented evidence is required for patients who have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy 4. ECOG performance status of 0-2 5. No prior hormone therapy (e.g. tamoxifen, aromatase inhibitor, progestogens, anti-androgens) 6. At least one line of prior platinum-based chemotherapy 7. Measurable or evaluable disease (if not measurable by RECIST v1.1 criteria, patients must be evaluable by GCIG CA125 criteria). See Appendix 2 8. Archival primary tumour tissue (FFPE or 8-10 unstained slides) must be available. Otherwise, a biopsy must be carried out to obtain sufficient tissue for histological assessment 9. No evidence of pre-existing uncontrolled hypertension as documented by two baseline blood pressure readings taken at least an hour apart. The baseline systolic blood pressure readings must be <160 and the baseline diastolic blood pressure readings must be <95 mmHg. Patients whose hypertension is controlled by antihypertensive therapies are eligible 10. Haematological and biochemical indices within acceptable specifed ranges 11. Aged 18 years or over 12. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
Key exclusion criteria	1. Tumours of mucinous, clear cell, malignant mixed mesodermal (MMMT) or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours) 2. Radiotherapy (except for palliative reasons) or chemotherapy within the preceding three weeks (four weeks for investigational agent or within five half-lives of the investigational agent, whichever is longer) 3. Persistent grade 2 or greater toxicities from any cause except for alopecia or grade 2 peripheral neuropathy 4. Known leptomeningeal involvement or brain metastases 5. Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism 6. Unresolved bowel obstruction 7. Major surgery within four weeks prior to entry to the study or minor surgery within two weeks of entry into the study and from which the patient has not yet recovered 8. Treatment with warfarin. Patients on warfarin for DVT/PE can be converted to LMWH at least one week prior to commencement of trial treatment 9. At high medical risk, as deemed by the Principal Investigator, because of non-malignant systemic disease including active uncontrolled infection 10. Known to be serologically positive for hepatitis B and/or hepatitis C 11. Active or uncontrolled autoimmune disease that may require corticosteroid therapy 12. History of clinically significant heart disease, e.g. myocardial infarction or arterial thrombotic event within six months, severe or unstable angina, or New York Heart Association Class III or IV heart disease 13. Systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg documented on at least two different occasions [Note: Hypertension controlled by antihypertensive therapy is permitted]. 14. Any other active malignancy requiring treatment/or whose prognosis will prevent readout from trial endpoints 15. Patients for whom treatment with prednisone or prednisolone is contraindicated 16. Patients participating in or planning to participate in another interventional clinical trial. Participation in an observational trial is acceptable 17. Any other condition which, in the Investigators opinion, would not make the patient a good candidate for the clinical trial
Date of first enrolment	15/07/2013
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Royal Marsden NHS Foundation Trust

London
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		29/12/2020	16/04/2021	Yes	No
Abstract results	results presented at the European Society of Medical Oncology (ESMO) conference	01/10/2016	26/10/2020	No	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			09/08/2022	No	Yes

Editorial Notes

09/08/2022: A link to plain English results summary on CRUK was added.
16/04/2021: Publication reference added.
26/10/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.