EUCTR2013-001714-15-AT进行中（未招募）1 期
Phase II trial of capecitabine (Xeloda®) + nab-paclitaxel (Abraxane®) in patients with metastatic pancreatic cancer - Met.Panc.01
Med. Univ. Wien, Klinik f. Innere Med. I, Onkologie0 个研究点目标入组 30 人开始时间: 2013年6月18日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Patients with histologically or cytologically confirmed metastatic
- •pancreatic adenocarcinoma
- •- Radiologically determinable disease defined by RECIST version 1.1
- •within 4 weeks prior to study treatment initiation
- •- ECOG performance status of 0 or 1
- •- Adequate hematologic function, as follows
- •- Adequate renal function
- •- Adequate hepatic function
- •- Any age = 18 = 75 years
- •- Life expectancy > 3 months at baseline
- •- Informed consent signed prior to any study specific procedure
- •- Ability to comply with the protocol and attended follow up
- •- Women of childbearing potential must have a negative serum
- •pregnancy test done 1 week prior to study drug administration.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •- Major surgery within 4 weeks prior start of study treatment
- •- Any past or current history of other invasive malignancies less
- •than 5 years prior to study inclusion
- •- Clinical suspicion of brain metastases
- •- Patient has only locally advanced disease
- •- Patients may not have received previous treatment for metastatic or locally advanced, non- or borderline resectable disease. Prior adjuvant treatment with Gemcitabine is allowed,though tumor recurrence must have occurred = 6 months after the last treatment.
- •- Active infection requiring systemic treatment or any uncontrolled infections < 14 days prior to treatment initiation
- •- Concurrent participation in other clinical trials
- •- Pregnancy, lactation, patients (and patients with partners) of childbearing potential not willing to use effective means of contraception until six months after completion of study treatment
- •- Any known hypersensitivity/allergic reaction to any of the
- •components of study treatments
- •- History of connective tissue disorders (eg, lupus, scleroderma, ateritis nodosa).
- •- Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- •- Any severe and/or uncontrolled medical conditions including but not limited to:
- •o Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 12 months prior to enrolment, serious uncontrolled cardiac arrhythmia
- •o Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
- •o Active skin, mucosa, ocular or GI disorders of grade > 1
- •o Other severe acute or chronic medical or psychiatric
- •condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or IMP administration, or which, in the judgment of the investigator, would make the patient inappropriate for enrolment into this study
研究者
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