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
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Meabco A/S
- Enrollment
- 36
- Locations
- 6
- Primary Endpoint
- Change (%) in the sum of diameters of target lesions
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: 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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change (%) in the sum of diameters of target lesions
Time Frame: 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.
Secondary Outcomes
- 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)