CORAL: Cancer of the OvaRy Abiraterone triaL
ISRCTN | ISRCTN63407050 |
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DOI | https://doi.org/10.1186/ISRCTN63407050 |
EudraCT/CTIS number | 2013-000293-29 |
Secondary identifying numbers | ICR-CTSU/2012/10038 |
- 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
Contact information
Dr Susana Banerjee
Scientific
Scientific
The Royal Marsden NHS Foundation Trust
Gynaecology Unit
Downs Road
Sutton
London
SM2 5PT
United Kingdom
coral-icrctsu@icr.ac.uk |
Study information
Study design | Prospective open-label non-randomised two-stage phase II clinical trial |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Please use the contact information provided to request a Patient 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 |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Abiraterone |
Primary outcome measure | 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. |
Secondary outcome measures | 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. |
Overall study start date | 15/07/2013 |
Completion date | 14/07/2016 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 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
- England
- United Kingdom
Study participating centre
The Royal Marsden NHS Foundation Trust
London
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
The Institute of Cancer Research (UK)
Research organisation
Research organisation
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Website | http://www.icr.ac.uk/ |
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https://ror.org/043jzw605 |
Funders
Funder type
Industry
Study drug and funding provided by Janssen-Cilag
No information available
CORAL has received endorsement from Cancer Research UK (CRUK) (ref: A16037)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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? |
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Abstract results | results presented at the European Society of Medical Oncology (ESMO) conference | 01/10/2016 | 26/10/2020 | No | No |
Results article | 29/12/2020 | 16/04/2021 | Yes | No | |
Plain English results | 09/08/2022 | No | Yes | ||
HRA research summary | 28/06/2023 | No | No |
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.