Estimation of the Optimal Treatment Duration and Cumulative Dose of BP-C1 in Breast Cancer Patients With Distant Metastases: a Dose-response Study (IC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Meabco A/S
- 入组人数
- 29
- 试验地点
- 7
- 主要终点
- Sum Common Toxicity Criteria score (Sum CTC score)
研究概览
简要总结
The purpose of this study is to establish an optimal treatment duration and tolerable cumulative dose for BP-C1 in the treatment of metastatic breast cancer patients who had previously undergone 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 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 an open-label, non-randomised, single-group, multi-centre study with a sequential safety design. The study consists of two parts: dose-response part and follow-up study.
Dose-response part: Patients who have completed the first 32-day treatment period with BP-C1 from Day 1 to Day 32 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4, and having a maximum of "moderate" toxicity at the end of treatment are offered to continue in the second 32-day treatment period with BP-C1 from Day 33 to Day 64 under protocol BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients who have completed 32-day treatment with BP-C1 (under protocols BMC2011-1, MBC-BPC1/IIA, BMC2012-4), having increase in toxicity not above moderate level, and having no progression of the disease. In accordance with inclusion criteria checked in the studies BMC2011-1, MBC-BPC1/IIA, or BMC2012-4, the patients are between 18 and 80 years with metastatic breast cancer (stage IV), had previously underwent at least third line chemotherapy, and have an expected survival time of at least 3 months.
排除标准
- •Severe or life-threatening increase in toxicity after preceding 32-day treatment with BP-C
- •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 <0.70 or international normalised ratio (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 3 weeks 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
Dose-response part: patients who have completed the first 32-day treatment period with BP-C1 under Protocol BMC2011-1/Protocol MBC-BPC1/IIB or Protocol BMC2012-4, and having a maximum of "moderate" toxicity at the end of treatment are offered to continue in the second 32-day treatment period with BP-C1 under the protocol BMC2011-02. Patients completing 64-day treatment period with BP-C1 will be followed up for 28 days.
Follow-up study: the patients will be given BP-C1 as long as they obtain benefit from the treatment (i.e. until disease progression or increase in toxicity not above "moderate" grade).
干预措施: BP-C1 (Drug)
结局指标
主要结局
Sum Common Toxicity Criteria score (Sum CTC score)
时间窗: baseline to Day 64 of treatment period
Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Sum CTC score will be calculated by taking the sum of each variable across all categories.
Maximum Common Toxicity Criteria score (Maximum CTC score)
时间窗: baseline to Day 64 of treatment period
Toxicity will be assessed according to National Cancer Institute Common Toxicity Criteria version 2.0 (CTC v2.0). The CTC v2.0 is divided in 15 toxicity categories (variables); each category is divided by corresponding sub-variables. Each sub-variable is measured on five-point fixed scale from 0 to 4: 0-none, 1-mild, 2-moderate, 3-severe, 4-life-threatening. However, in this trial each sub-variable will be measured on modified fixed scale from 1 to 4: 1-none or mild, 2-moderate, 3-severe, 4-life-threatening. The classification of each toxicity variable will be judged based on the largest observed value for its sub-variables. The Maximum CTC score will be calculated by taking the maximum value among all variables across all categories.
次要结局
- Karnofsky Performance Status score (KPS score)(baseline to Day 64 of treatment period)
- Treatment response(baseline to Day 64 of treatment period)
- Changes in sub-scores of the specific quality of life questionnaire (EORTC QLQ-BR23)(baseline to Day 64 of treatment period)
- Number of registered adverse events(baseline to Day 28 of follow-up period)
- Change (%) in the sum of diameters of target lesions(baseline to Day 64 of treatment period)
- Changes in sub-scores of the three major scales of general quality of life questionnaire (EORTC QLQ-C30)(baseline to Day 64 of treatment period)