EUCTR2014-002620-26-GB进行中（未招募）1 期
A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 149
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
入选标准
- •1.Women aged 18 years or older.
- •2.Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast, including ER+, PR+, and TNBC.
- •3.Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- •4.Modified GPS of 1 or 2 as defined below:
- •a.mGPS of 1: CRP > 10 mg/L and albumin = 35 g/L
- •b.mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L
- •5.ECOG performance status 0 to 2 (see Appendix D).
- •6.Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease.
- •7.Subjects with hormone-receptor positive tumors (ER+ and/or PR+) must have failed available appropriate lines of hormonal therapy, unless intolerant to hormonal therapy or hormonal therapy is not considered to be clinically appropriate.
- •8.= 2 weeks elapsed from the completion of previous treatment regimen and subjects must have recovered (eg, = Grade 2), or be at a new stable baseline from any related toxicities.
- •9.Radiographically measurable or evaluable disease (based on local evaluation), per RECIST (v1.1).
- •a.Measurable lesions (eg, target lesions) may be in the field of prior radiation; however, there must be at least a 4-week period between the last radiation treatment and demonstration of interval progression of the lesion compared with the baseline scan documenting disease status for the lesion to be considered measurable.
- •b.Palliative radiotherapy to other disease sites (eg, nontarget lesions) is allowed provided there are other sites of disease or subsequent progression of the disease in the radiation field, and = 2 weeks have elapsed since the completion of radiotherapy and all treatment-related toxicities have resolved or are at a new stable baseline.
- •10.Able to swallow and retain oral medication.
- •11.Females of childbearing potential, must have a negative serum pregnancy test at screening. All female subjects of childbearing potential must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through the safety follow-up if of childbearing potential. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subjects and their understanding confirmed.
- •12.Ability to comprehend and willingness to sign an informed consent form (ICF).
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •1.Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease.
- •2.Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting, or neoadjuvant and adjuvant therapies).
- •3.Unknown hormone-receptor status (ER and PR).
- •6.Untreated brain metastases, or brain metastases that have progressed Subjects with treated and clinically stable brain metastases and off all corticosteroids for at least 4 weeks are eligible.
- •7.Inadequate renal, hepatic, and bone marrow function as evidenced by:
- •a.Absolute neutrophil count < 1.5 × 109/L.
- •b.Platelets < 75 × 109/L.
- •c.Hemoglobin < 9 g/dL (transfusions are permitted to achieve baseline hemoglobin level).
- •d.ALT/AST > 2.5 × upper limit of normal (ULN); or > 5 × ULN in the presence of liver metastases.
- •e.Total bilirubin > 1.5 × ULN (if total bilirubin is > 1.5 × ULN then direct bilirubin must be = 1.5 × ULN).
- •f.Creatinine clearance < 50 mL/min measured or calculated by Cockroft-Gault equation or the estimated glomerular filtration rate < 50 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.
- •8.Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral or psychiatric disease.
- •9.Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
- •10.Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy.
- •11.Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment.
- •12.Concurrent anticancer therapy
- •13.Subjects who participated in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) before first dose. For investigational agents with long half-lives, enrollment before the fifth half-life requires medical monitor approval.
- •14.Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
- •15.Recent (= 3 months) history or ongoing partial or complete bowel obstruction.
- •16.Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency, or other known hypersensitivity to active substances, including 5 FU, ruxolitinib, or any of their excipients.
- •17.Known history of human immunodeficiency virus infection.
- •18.Active hepatitis B or C infection that requires treatment.
- •19.Unwilling to be transfused with blood components.
- •20.Prior treatment with a JAK-inhibitor for any indication.
研究者
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