ICON9 is a research study investigating patients with recurrent ovarian, fallopian tube or primary peritoneal cancer, who have had their tumour shrunk by chemotherapy. The study will address whether such patients may benefit from maintenance treatment with two new anti-cancer, orally-administrated drugs called olaparib and cediranib.
- Conditions
- High grade serous or endometrioid ovarian, fallopian and peritoneal cancerMedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-000161-75-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 618
1.Histologically proven diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with second-line platinum-based chemotherapy. Patients may be included post-surgery for relapsed disease if undertaken more than 6 months after progression from first-line therapy.
2.Patients must have had CT or MRI proven relapsed disease (measureable by RECIST 1.1 or non-measureable abnormalities supported by GCIG CA125 criteria of progression), or have had debulking surgery for first relapse.
3.Patients showing response to chemotherapy mid-treatment (post 3 or 4 cycles), either by GCIG CA125 criteria or ‘partial response’ on CT/MRI scan, or no evidence of progression having undergone surgical debulking, should be approached for ICON9 trial registration to allow for BRCA mutation status to be assessed (germline and/or somatic).
4.Completed a minimum of 4 cycles (and maximum of 6 cycles) of platinum-based chemotherapy for first relapse (2nd line treatment) with at least a partial response on imaging (CT or MRI) by RECIST 1.1 if measureable disease, or CA125 response by GCIG criteria if non-measurable disease. No CT/MRI or CA125 evidence of progression after surgical debulking and chemotherapy (above).
5.Prior front-line maintenance therapy with bevacizumab is permitted.
6.ECOG performance status 0-1.
7.Adequate bone marrow function, liver and renal function.
8.Availability of archival diagnostic tumour sample or tumour samples at relapse if patient has undergone further biopsy or surgical debulking.
9.Adequately controlled blood pressure (systolic blood pressure [SBP] =140 mmHg; diastolic blood pressure [DBP] = 90mmHg) on maximum of 3 antihypertensive medications.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168
1.Non-epithelial ovarian cancer, carcinosarcoma and mucinous carcinomas, ovarian clear-cell carcinoma.
2.Cerebrovascular accident (including transient ischemic attacks) within last 12 months.
3.Gastrointestinal impairment that could affect ability to take, or absorb oral medicines including sub-acute or complete bowel obstruction.
4.Symptomatic or clinically significant inflammatory bowel disease (Crohn’s disease or ulcerative colitis.
5.Evidence of severe or uncontrolled cardiac disease.
6.Evidence of active bleeding or bleeding diathesis.
7. Previous treatment with VEGFR tyrosine kinase inhibitors or PARP inhibitors are not permitted.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method