EUCTR2015-000580-14-FR进行中（未招募）1 期
A single arm, open-label, phase II study to assess the efficacy of rucaparib in metastatic breast cancer patients with a BRCAness genomic signature. - RUBY
ICANCER0 个研究点目标入组 40 人开始时间: 2015年6月22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
- 40
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. Women with histologically proven breast cancer.
- •2. No Her2 over-expression.
- •3. Progressive metastatic disease previously treated with at least one line of chemotherapy at the metastatic setting.
- •4. Molecular analysis using the Affymetrix (CytoScan HD, SNP 6.0, or OncoScan) array available from the SAFIR02 protocol, or from other programs.
- •5. BRCAness profile as defined by the Clovis genomic signature or BRCA1/2 somatic mutation (without known germline BRCA).
- •6. Age = 18 years
- •7. WHO Performance Status 0/1
- •8. Presence of measurable target lesion according to RECIST criteria v1.1
- •9. Patients will have had at least a 21-day wash-out period from last chemotherapy or targeted therapy administration prior to inclusion and should have recover (grade =1) from all residual toxicities, excluding alopecia.
- •10. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 6 months after the last dose of study drug.
- •11. Women of childbearing potential must have a negative serum pregnancy test done within 14 days of enrollment and/or urine pregnancy test 72 hours prior to the administration of the study drug.
- •12. Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
- •13. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
- •14. Patient with social insurance coverage.
- •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 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. BRCA1 or 2 germline known mutation.
- •2. Life expectancy < 3 months.
- •3. Less than 14 days from radiotherapy (whatever the indication). Fields should not have involved all target lesions.
- •4. Patients previously treated with a PARP inhibitor.
- •5. Spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).
- •6. Patients with all target lesions in a previously irradiated region, except if clear progression has been observed prior to study in at least one of them
- •7. Inability to swallow
- •8. Major problem with intestinal absorption
- •9. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.
- •10. Evidence of severe or uncontrolled systemic disease (active bleeding diatheses, or active Hepatitis B, C and HIV)
- •11. Previous history of myelodysplastic syndrome
- •12. History of hypersensitivity to active or inactive excipients of the rucaparib.
- •13. Toxicities of grade =2 from any previous anti-cancer therapy, with the exception of alopecia.
- •14. Altered haematopoietic or organ function, as indicated by the following criteria:
- •Polynuclear neutrophils < 1.5 x 10^9/L
- •Platelets < 100 x 10^9/L
- •Haemoglobin < 90 g/L
- •ALAT/ASAT > 2.5x ULN in the absence of or > 5x ULN in the presence of liver metastases
- •Bilirubin > 1.5xULN
- •Creatinine clearance =30 mL/min (measured or calculated by Cockroft and Gault formula
- •15. Women who are pregnant.
- •16. Patients using drugs that are known potent inhibitors or potent inducers of CYP1A2 or CYP3A4 are not eligible if those treatments cannot be substituted before inclusion
- •17. Any condition which in the Investigator’s opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
- •18. Individuals deprived of liberty or placed under the authority of a tutor.
研究者
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