A Randomized, Double Blind and Placebo Controlled Multicenter Study Comparing BP-C1 and Equal Looking Placebo in Metastatic Breast Cancer Patients. A Phase IIB Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Meabco A/S
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Change (%) in the sum of diameters of target lesions
研究概览
简要总结
The purpose of this study is to determine whether BP-C1 is effective in the treatment of metastatic breast cancer patients who had previously received at least three lines of chemotherapy.
详细描述
BP-C1, solution for injection 0.05%, is currently being developed for treatment of patients with metastatic breast cancer with palliative intent. Active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin. 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 of metastatic breast 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;
- demonstrates efficacy comparable to cisplatin and much higher than carboplatin (in-vitro; in-vivo data);
- exerts an additional immunomodulatory activity.
This study is a randomised, double-blind, placebo-controlled, multicentre, phase IIb study. The eligible patients will be allocated (1:1) to either BP-C1 arm or Placebo arm and treated once daily for 32 days. The patients allocated to Placebo arm will cross over to BP-C1 treatment for 32 days when progression of the cancer will be documented and latest after 32-day treatment with Placebo. After 32-day treatment with BP-C1 the patients are invited to participate in the study BMC2011-02 to continue open-label BP-C1 treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with histologically verified metastatic breast cancer (stage IV) with measurable metastases, between 18 and 80 years of age, who had undergone at least three lines of chemotherapy and had an expected survival time of at least 3 months.
- •Exclusion criteria:
- •Patients fulfilling at least one of the following criteria will be excluded from participation in the study:
- •Abnormal liver function classified as total bilirubin >34 μmol/L or ALAT > 3 times of the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5хULN.
- •Abnormal kidney function defined by serum creatinine >120 μmol/L.
- •Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10; INR >1.
- •Verified metastases to the brain.
- •Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.
- •Abnormal hematology status defined by hemoglobin < 9.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/L.
- •Clinically significant abnormal ECG.
- •Karnofsky performance status score <60%.
- •Pregnant or breast feeding women.
- •Women of fertile age who do not want to be tested for possible pregnancy.
- •Fertile female who do not want to use safe protection against pregnancy, starting one month before the start of the study treatment and lasting at least six weeks after.
- •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.
排除标准
- 未提供
研究组 & 干预措施
BP-C1
Patients randomized to BP-C1 arm will be treated for 32 consecutive days. Patients who respond to treatment and do not experience untolerated toxicity are invited to participate in the BMC2011-02 study, where they will be offered to continue treatment with BP-C1.
干预措施: BP-C1 (Drug)
Placebo
Patients randomized to Placebo arm will be treated for 32 consecutive days. Thereafter the patients will cross over to 32-day treatment with BP-C1. Patients who respond to treatment and do not experience untolerated toxicity are invited to participate in the BMC2011-02 study, where they will be offered to continue treatment with BP-C1.
干预措施: Placebo (Drug)
结局指标
主要结局
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) with contrasting using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
次要结局
- Number of non-target lesions(baseline to Day 32 of treatment)
- Treatment response(baseline to Day 32 of treatment)
- Karnofsky Performance Status (KPS) score(baseline to Day 16 and Day 32 of treatment)
- Sum CTC score(baseline to Day 16 and Day 32 of treatment)
- Number of registered adverse events(baseline to Day 32 of treatment)
- Changes in the scores of the general questionnaire EORTC QLQ-C30 ("Physical activity problem last week", "Discomfort last week", "Health and quality of life")(baseline to Day 16 and Day 32 of treatment)
- Number of target lesions(baseline to Day 32 of treatment)
- Changes in three separate scores of the specific questionnaire EORTC QLQ-BR23 ("Breast cancer treatment problem last week", "Sexual interest and activity last four weeks", "Breast cancer related pain and discomfort last week")(baseline to Day 16 and Day 32 of treatment)
- Change in Maximum Common Toxicity Criteria (CTC) score(baseline to Day 16 and Day 32 of treatment)