EUCTR2016-002689-30-ES进行中（未招募）1 期
Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI for progressing brain metastases in patients with HER2-negative breast cancer - PHENOMENA
Medica Scientia Innovation Research (MedSIR ARO)0 个研究点开始时间: 2017年1月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- All
入选标准
- •1. Female or male patients > 18 years
- •2. Patients must have a diagnosis of metastatic breast cancer.
- •3. Patients should have been pretreated with taxanes at any
- •time prior to the study enrolment if not formally
- •contraindicated.
- •4. At least one prior chemotherapy regimen for advanced
- •5. Evidence of new and/or progressive brain metastases
- •following previous WBRT and/or SRS and/or surgery.
- •6. At least one brain lesion needed to be measurable (=10 mm
- •on T1-weighted, gadolinium-enhanced magnetic resonance
- •7. HER2 negative breast cancer defined as 0 - 1+ by
- •immunohistochemistry or FISH negative result.
- •8. ECOG performance status <2.
- •9. Life expectancy >12 weeks.
- •10. Patients must have sufficient organ and marrow function as
- •defined below:
- •a. Hematopoietic parameters:
- •i. Absolute neutrophil count = 1,5 x 109/L
- •ii. Platelets = 100 x 109/L
- •iii. Haemoglobin = 9 mg/dL
- •b. Hepatic parameters:i. Total bilirubin = 1.5 mg/dL
- •ii. AST (SGOT)/ALT (SGPT) = 2.5 X
- •institutional upper limit of normal
- •c. Renal parameters:
- •i. Creatinine = 1.5 X institutional upper limits of
- •ii. Creatinine clearance = 60 mL/min/1.73 m2 for
- •pts w/ creatinine levels > institutional normal.
- •11. Participants of childbearing potential must agree to use
- •adequate contraception prior to study entry and for the
- •duration of study participation as well as a negative serum
- •pregnancy test within 7 days of study enrolment.
- •12. Ability to understand and the willingness to sign a written
- •informed consent.
- •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 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
排除标准
- •1. Patients must not have previously received nal-IRI or
- •any other form of irinotecan, conventional or liposomal.
- •2. Patients who have received prior anti-cancer treatment
- •with chemotherapy, endocrine therapy, immunotherapy
- •or radiotherapy within 3 weeks (6 weeks for nitrosoureas
- •or mitomycin-C) prior to starting study treatment.
- •3. Radiation therapy encompassing more than 30% of
- •bone marrow.
- •4. Significant chronic gastrointestinal disorder with diarrhea
- •as a major symptom (i.e Crohn’s disease, ulcerative
- •colitis, malabsorption, or grade = 2 diarrhea of any
- •etiology at baseline)
- •5. Have a serious concomitant systemic disorder (e.g.
- •active infection including HIV, or cardiac disease)
- •incompatible with the study (at the discretion of
- •investigator), previous history of bleeding diathesis, or
- •treatment with Sintrom.
- •6. Patients who have symptomatic lymphangitis, dyspnoea
- •at rest or meningeal carcinomatosis. (Patients with
- •asymptomatic involvement may be enrolled in the study.)
- •7. Patients must be recovered from any clinically relevant
- •toxic effects of any prior surgery, radiotherapy or other
- •therapy intended for the treatment of breast cancer. For
- •peripheral neuropathy, up to CTCAE (v4.0) Grade 2 is
- •acceptable for patients with pre-existing condition.
- •8. Patients may not be receiving any other investigational
- •or anticancer agents while on the study.
- •9. History of other malignancies, which could affect
- •compliance with the protocol or interpretation of the
- •results. Patients with malignancies diagnosed more than
- •5 years prior to study day 1, adequately treated
- •carcinoma in situ of the cervix or basal or squamous cell
- •skin are generally eligible.
- •10. Pregnant or lactating women.
- •11. NYHA Class III or IV congestive heart failure, ventricular
- •arrhythmias or uncontrolled blood pressure. Or known
- •abnormal ECG with clinically significant abnormal
- •12. Active infection or an unexplained fever >38.5°C
- •(excluding tumoral fever), which in the physician’s
- •opinion might compromise the patient’s health.
- •13. Patients with other significant disease or disorders that,
- •in the Investigator's opinion, would exclude the patient
- •from the study.
- •14. Current use or any use in the last two weeks of strong
- •CYP3A-enzyme inducers/inhibitors and/or strong
- •UGT1A inhibitors
- •15. Known hypersensitivity to any of the components of
- •nanoliposomal irinotecan (nal-IRI) other liposomal
- •irinotecan formulations or irinotecan.
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