EUCTR2014-004653-14-GB进行中（未招募）1 期
A Phase III, open label, multicentre randomised clinical study comparing Acelarin (NUC-1031) with Gemcitabine in patient with metastatic pancreatic carcinoma.(ACELARATE) - ACELARATE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 328
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
- •a)Age = 18 years.
- •b)Histologically or cytologically proven pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas.*
- •c)Metastatic disease precluding curative surgical resection or definitive locally directed therapies such as chemo radiation. Patients who have relapsed following previously resected pancreatic cancer can be included.
- •d)Contrast enhanced computerised tomography (CT) scan of the thorax, abdomen and pelvis within 28 days prior to commencing treatment
- •e)Unidimensionally measurable disease.
- •f)ECOG performance status 0, 1 or 2 where treatment with combination chemotherapy is not deemed appropriate or is declined by the patient.
- •g)Platelets =100 x 109/l; neutrophils = 1.5 x 109/l at entry.
- •h)Documented life expectancy > 3 months.
- •i)Informed written consent.
- •*Patients will be approached for consenting to provide either an additional core of tissue material for biomarker discovery at the same time as a diagnostic biopsy or in those patients that have already had a diagnostic biopsy to undergo a second biopsy after randomisation into the trial. Neither of these biopsies is compulsory. Patients who don't wish to have extra tissue taken for Biomarker discovery will be approached for consent to released surplus tissue from the original diagnostic specimen if this exists.
- •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 218
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •a)Laboratory results:
- •Serum bilirubin = 1.5x the upper limit of reference range (ULRR).
- •Haemoglobin < 10G/dl
- •Creatinine clearance < 30 mL/minute (calculated by Cockcroft-Gault formula)
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULN or > 5x ULN if judged by the investigator to be related to liver metastases.
- •b)Medical or psychiatric conditions compromising informed consent.
- •c)Intracerebral metastases or meningeal carcinomatosis.
- •d)Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- •e)Pregnancy or breast feeding.
- •f)Previous chemotherapy for locally advanced and metastatic disease. Adjuvant chemotherapy for resected pancreatic cancer will be permitted provided that chemotherapy was completed > 12 months previously.
- •g)Radiotherapy within the last 4 weeks prior to start of study treatment.
- •h)Concurrent malignancies or invasive cancers diagnosed within past 5 years except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer.
- •i) Hypersensitivity to gemcitabine or any of the excipients of gemcitabine or Acelarin (NUC-1031).
- •j) j)All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be from the list below, the other must be a condom1 or abstaining from sexual intercourse, until six months after treatment has ended:
- •oCombined (oestrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: either oral, intravaginal or transdermal.
- •oProgesterone-only hormonal contraception associated with inhibition of ovulation: either oral, injectable or implantable.
- •oIntra-uterine device (IUD)
- •oIntra-uterine hormone-releasing system (IUS)
- •oBilateral tubal occlusion
- •oVasectomised partner2
- •oSexual abstinence3
- •1Male or female condom with or without spermicide is not an acceptable method of contraception alone.
- •2 Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the woman of childbearing potential trial participant and that the vasectomised partner has received medical assessment of the surgical success.
- •3 In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
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