EUCTR2018-002886-21-FR进行中（未招募）1 期
A Phase III randomized study evaluating gemcitabine and paclitaxel versus gemcitabine alone after FOLFIRINOX failure or intolerance in Metastatic Pancreatic Ductal Adenocarcinoma. - GEMPAX
ICANCER0 个研究点目标入组 210 人开始时间: 2018年10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
- 210
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. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
- •2. Age =18 years old.
- •3. At least one evaluable lesion according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) outside any previously irradiated area.
- •4. Failure of first line FOLFIRINOX therapy due to progressive disease during or within 3 months after the end of therapy (including mFOLFIRINOX in adjuvant setting) or patient with FOLFIRINOX intolerance
- •5. Performance Status (PS) ECOG 0 to 2.
- •6. Life expectancy =12 weeks.
- •7. Negative serology (HIV, hepatitis B and C)
- •8. Adequate organs function:
- •- Absolute neutrophils count =1.5x109/L
- •- Platelets count =100x109/L
- •- Haemoglobin =9 g/dl
- •- Serum bilirubin levels <2 times upper limit of normal (ULN), up to 2.5 times ULN in case of hepatic metastasis (biliary drainage allowed)
- •- Transaminases <5 times ULN.
- •9. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
- •10. Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment/therapy
- •11. Patients affiliated to the social security system
- •12. Patient must have signed a written informed consent form prior to any trial specific procedures
- •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 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Any other primary tumor or secondary malignancy except basal cell carcinoma of the skin or in situ carcinoma of the cervix uteri (patients adequately treated for other malignancies and without tumor during the last 5 years are eligible).
- •2. Known cerebral metastasis.
- •3. Uncontrolled severe infections.
- •4. Patients with Kaposi’s sarcoma
- •5. Peripheral neuropathy exceeding CTCAE (Common Terminology Criteria for Adverse Events) v5.0 grade 2.
- •6. Previous treatment with taxane.
- •7. Patients with known allergy or severe hypersensitivity to any of the trial drugs or any of the trial drug excipients
- •8. Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment.
- •9. Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.
- •10. Participation in another clinical trial within 14 days prior to randomization.
研究者
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