The Effect of BP-C1 in Treatment of Inoperable Pancreatic Cancer Patients: A Single Centre Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Meabco A/S
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Sum CTC score
研究概览
简要总结
The aim of this study is to investigate the short-term effect and tolerability BP-C1 in patients with metastatic pancreatic cancer who has undergone guideline-recommended chemotherapy.
详细描述
BP-C1, solution for injections 0.05%, is currently being developed for treatment of patients with metastatic breast cancer and metastatic pancreatic cancer with palliative intent. Active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a complex between cis-diammineplatinum(II) derived core and an amphiphilic polymer, containing a composition of benzene polycarboxylic acids. The amphiphilic characteristics of the polymer have resulted in a product with clear and significantly altered and improved properties compared to other platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin.
BP-C1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin), additionally offering the following advantages that ensure favourable outcome of treatment in metastatic cancer patients:
- injectable solution (intramuscular) does not cause injection site reactions;
- can be administered at home by a nurse or a patient;
- has an improved pharmacokinetic profile;
- exerts an additional immunomodulatory activity.
BP-C2 is a novel lignin-derived polyphenolic composition with ammonium molybdate. BP-C2, given orally, is believed to reduce the toxicity of chemotherapeutic agents.
This is a single center, two arm, open label pilot study (phase IIa). The eligible patients will be allocated either to BP-C1 arm or to BP-C1+BP-C2 arm and treated for 32 days with further follow-up for 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all genders between 18 and 80 years of age with metastatic pancreatic cancer (unresectable pancreatic cancer with increased levels of cancer antigen 19-9), who had an expected survival time of at least 3 months.
排除标准
- •Patients fulfilling at least one of the following criteria will be excluded from participation in the study:
- •Abnormal liver function classified as total bilirubin >136 μmol/L (8.0 mg/dL)
- •Abnormal kidney function defined by serum creatinine >120 μmol/L (1.5 mg/dL).
- •Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10 < 0.7 or international normalized ratio >1.
- •Verified metastases to the brain.
- •Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
- •Abnormal haematology status defined by hemoglobin < 6.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/L.
- •Clinically significant abnormal ECG.
- •Karnofsky performance status score <60%.
- •Pregnancy or breast-feeding.
- •Women of fertile age who do not want to be tested for possible pregnancy.
- •Uncontrolled bacterial, viral, fungal or parasite infection.
- •Under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment.
- •Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment.
- •Not able to understand information.
- •Not willing or not able to give written consent to participate in the study.
研究组 & 干预措施
BP-C1
Patients will be treated with BP-C1 for 32 consecutive days
干预措施: BP-C1 (Drug)
BP-C1+BP-C2
Patients will be treated with BP-C1 and BP-C2 for 32 consecutive days
干预措施: BP-C1 (Drug)
BP-C1+BP-C2
Patients will be treated with BP-C1 and BP-C2 for 32 consecutive days
干预措施: BP-C2 (Drug)
结局指标
主要结局
Sum CTC score
时间窗: baseline to Day 32 of treatment
The Sum CTC score will be a sum of all registered CTC scores by 15 categories
Maximum Common Toxicity Criteria (CTC) score
时间窗: baseline to Day 32 of treatment
Maximum CTC score will be recorded using NCI Common Toxicity Criteria v2.0 divided in 15 categories
Change (%) in the sum of diameters of target lesions
时间窗: baseline to Day 32 of treatment
Diameter of target lesions will be measured by computer tomography (CT) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
次要结局
- Treatment response(baseline to Day 32 of treatment)
- Scores of the general quality of life cancer questionnaire (EORTC QLQ-C30)(baseline to Day 16 and Day 32 of treatment)
- Number of registered adverse events(screening to Day 32 of treatment and Day 28 of follow-up)