BP-C1 in Metastatic Breast Cancer Patients
Condition: Metastatic Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label, non-randomized phase I single-armed study in women with
      metastatic breast cancer (MBC) who have previously undergone all available standard
      chemotherapy regimens. The purpose of the study is to estimate the pharmacokinetics (PK)
      after single dose and multiple dose of BP-C1, investigate interleukin levels during BP-C1
      treatment and assess treatment response according to RECIST criteria.
    

Detailed description: 
      BP-C1, solution for injections 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 а 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.

      In this study six female patients with MBC who have previously undergone at least third line
      therapy will be enrolled. Each included patient will participate in a screening period
      (maximum duration of 21 days) following by 32-day treatment period and 28-day follow-up
      period.

      The patients will be treated with BP-C1(daily intramuscular injections) for 32 consecutive
      days. The study is undertaken to evaluate pharmacokinetics, pharmacodynamics and treatment
      effect of BP-C1.
    

Intervention name(s): BP-C1
Intervention type(s): Drug
Intervention description(s): BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days
Other intervention name(s): Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin; Benzene polycarboxylic acids complex with cis-diammineplatinum(II); Cis-diammineplatinum(II) complex, containing mono-deprotonated benzene-poly-carboxylic acids, derived from lignin, and hydroxyl group as O-donor ligands
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: BP-C1; Metronomic chemotherapy; Platinum analogue; Cis-diammineplatinum(II) complexed with a polymer containing benzene polycarboxylic acids derived from lignin; Benzene polycarboxylic acids complex with cis-diammineplatinum(II); Breast cancer; Cisplatin; Metastatic Breast Cancer; Cis-diammineplatinum(II) complex, containing mono-deprotonated benzene-poly-carboxylic acids, derived from lignin, and hydroxyl group as O-donor ligands