EUCTR2013-000293-29-GB进行中（未招募）1 期
A prospective, multi-centre, open label, non-randomised two stage phase II clinical trial evaluating the efficacy of abiraterone in patients with epithelial ovarian (including fallopian tube and primary peritoneal) cancer. - CORAL: Cancer of the OvaRy Abiraterone tria
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 47
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1) Patients must have 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:
- •Aged = 18 years having had bilateral salpingo-oophorectomy (BSO)
- •Aged = 45 years with intact uterus and amenorrhoeic for at least 12 months
- •FSH >40 U/L in patients who have had a hysterectomy and ovaries are intact (i.e. not had bilateral oophorectomy)
- •Documentary 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) Patients must not have had prior hormone therapy (e.g. tamoxifen, aromatase inhibitor, progestogens, anti-androgens)
- •6) Patients will have received 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)
- •8) Archival 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) Haematological and biochemical indices within acceptable ranges (as specified in the protocol)
- •10) Aged 18 years or over
- •11) Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up
- •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 47
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •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 commencement of trial treatment
- •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 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
- •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 Investigator’s opinion, would not make the patient a good candidate for the clinical trial.
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