EUCTR2014-000117-31-GB进行中（未招募）1 期
To assess the safety of continuous IV administration of the CXCR4 antagonist, plerixafor (Mozobil), at potentially active plasma concentrations and assess its impact on the immune microenvironment in patients with advanced pancreatic, high grade serous ovarian and colorectal adenocarcinomas - CAM-PLEX
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 26 人开始时间: 2015年7月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
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 are eligible for inclusion in the study if they meet all of the following criteria:
- •Aged 16 years or over.
- •Dose escalation phase only: Patients with inoperable, histologically proven locally advanced or metastatic pancreatic, high grade serous ovarian or colorectal adenocarcinoma, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy. OR;
- •Expansion phase only: Patients with inoperable, histologically proven locally advanced or metastatic pancreatic, refractory to conventional chemotherapy or a patient who has declined conventional chemotherapy.
- •Tumour lesions considered to be accessible for core biopsy and immunostaining assessment.
- •ECOG performance status 0-1.
- •Life expectancy of at least 12 weeks.
- •All women of child-bearing potential and all sexually active male patients must agree to use effective contraception methods throughout the study and for 3 months after the final dose of study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Patients are to be excluded from the study if they meet any of the following criteria:
- •Inadequate haematological function defined by:
- •oAbsolute neutrophil count (ANC) <1.5 x 109/L
- •oAbsolute lymphocyte count < normal level for institution
- •oHaemoglobin <9.0 g/dL (90 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding)
- •oPlatelets <100 x 109/L
- •oClotting; INR >1.3
- •Inadequate renal function defined by calculated creatinine clearance by Cockcroft-Gault of <50 ml/min.
- •Inadequate hepatic function defined by:
- •oAspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or >5 x in the presence of liver metastases
- •oTotal bilirubin >1.5 x ULN
- •Current treatment (within 28 days of entry) with chemotherapy, steroids or other immunosuppressive drugs.
- •Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality which in the judgement of the Investigator would place the patient at undue risk or interfere with the study.
- •Cardiac co-morbidity:
- •oPast history of significant rhythm disturbance (e.g. SVT, AF or ventricular irregularities)
- •oRequirement for pacemaker
- •oMyocardial infarction in the previous 6 months
- •oKnown medical history of proven postural hypotension.
- •Active infection.
- •Patients with known allergy to plerixafor or its excipients.
- •Patients known to have hepatitis B, hepatitis C or HIV infection.
- •Participation in any other interventional clinical trial
- •Women, who are pregnant, plan to become pregnant or are lactating (during the study or for up to 3 months after the last dose)
- •Men who plan to father a child within 3 months after the last dose
研究者
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