EUCTR2015-001119-11-DE进行中（未招募）1 期
A non-controlled, single arm, open label, Phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer - ParvOryx02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
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
- •- Age over 18 years,
- •- Informed consent,
- •- Histologically confirmed disease
- •- Disease progression despite first line therapy
- •- Eligibility for chemotherapy with gemcitabine
- •- ECOG performance scale 0 or 1,
- •- Consent for the sampling of biological specimens
- •- Adequate bone marrow and renal function
- •- Hepatic enzymes within predefined range
- •- Negative serology for HIV, HBV and HCV
- •- Exlusion of pregnany
- •- Use of adequate contraception in both genders
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Eligibility for surgical treatment,
- •- Symptomatic cerebral, pulmonal, and/or ossear metastases,
- •- Peritoneal carcinosis, Liver cirrhosis, Splenectomy
- •- Recent hospitalization
- •- Chemotherapy within 2 weeks prior to the first administration of the IMP,
- •- Signs of active, systemic infection within 7 days prior to the study inclusion
- •- Recent radiotherapy
- •- Contraindications for CT,
- •- Known allergy to iodinated contrast media,
- •- Recent participation in another interventional trial
- •- Presumed contact with pregnant women and/or infants <12 months of age within the 28 days after the first administration of the IMP.
研究者
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