EUCTR2014-003438-20-HU进行中（未招募）1 期
A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physician’s Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients carrying germline BRCA1/2 Mutations - SOLO3
Astra Zeneca AB0 个研究点目标入组 411 人开始时间: 2014年12月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 411
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
- •- Patients must be = 18 years of age during randomisation
- •- Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer (please refer to Appendix H). Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.
- •- Documented germline mutation in BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
- •- At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.
- •- Patients must have received at least 2 prior platinum based previous lines of chemotherapy for ovarian cancer prior randomisation
- •- Patients must be partially platinum sensitive (defined as progression 6 -12 months after the end of the last platinum based chemotherapy) or platinum sensitive (defined as progression > 12 months after the end of the last platinum based chemotherapy).
- •- Patients must be suitable to start treatment with single agent chemotherapy based on physician’s choice of weekly paclitaxel or topotecan or pegylated liposomal doxorubicin or gemcitabine.
- •- Patients must have normal organ and bone marrow function measured within 28 days of randomisation,
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See Appendix F)
- •- Patients must have a life expectancy = 16 weeks
- •- Patient must show or evidence of non-childbearing status: negative urine or serum pregnancy test within 7 days before first study drug dose (for women of childbearing potential) or must be postmenopausal.
- •Postmenopausal is defined as:
- •·Age = 60 yrs,
- •·Age < 60 and any one of the conditions below:
- •Amenorrheic for 1 year or more in the absence of chemotherapy and/or hormonal treatments;
- •Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) and oestradiol levels in the post menopausal range for women under 60; Radiation-induced oophorectomy with last menses >1 year ago; Chemotherapy-induced menopause with >1 year interval since last menses;
- •Surgical sterilisation (bilateral oophorectomy or hysterectomy)
- •- Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 309
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •BRCA 1 and/or BRCA2 mutations that are considered to be non
- •detrimental (e.g., Variants of uncertain clinical significance or Variant of unknown significance or Variant, favor polymorphism or benign polymorphism etc.)
- •-Previous randomisation in the present study
- •-Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
- •-Any previous treatment with a PARP inhibitor, including olaparib.
- •-Patients who have platinum resistant or refractory disease defined as progression during or within 6 months of their last platinum based chemotherapy
- •-Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for
- •=5 years. Patients with history of primary breast cancer may be eligible provided they completed their definitive anticancer treatment more than 3 years ago and they remain breast cancer disease free prior to randomisation
- •-Clinical significant abnormality on resting ECG
- •-Patients receiving any systemic chemotherapy within 3 weeks prior to first randomisation (or a longer period depending on the defined characteristics of the agents used) or radiotherapy within 2 weeks prior to randomisation.
- •-Previous single agent exposure to the selected chemotherapy regimen for randomisation
- •-Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole,
- •itraconazole, boosted protease inhibitors (ritonavir, indinavir, saquinavir,
- •telithromycin, nelfinavir, boceprevir, telaprevir) and clarithromycin
- •-Persistent toxicities (> Common Terminology Criteria for Adverse Event grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE grade 2 peripheral neuropathy.
- •-Patients with myelodysplastic syndrome/treatment related acute myeloid leukaemia (t-AML)
- •-Patients with symptomatic uncontrolled brain metastases.
- •-Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- •-Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- •-Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •-Breastfeeding women.
- •-Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- •-Patients with known active hepatitis B or C or HIV.
- •-Previous allogeneic bone marrow transplant or double umbilical cord blood transplantation
- •-Whole blood transfusions in the last 120 days prior to randomization
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